QC Assay Validation

Sarthak Biotech Pvt. Ltd.
Assay Method Validation Na e o! the Prod"ct# SA$C%P&'00 (ABL)(

Prepared By
Total Page:
QC/VLD/01
01-06
Checked By/ Approved By %ev!s!o( )o* : 00
Date of Issue/ ffect!ve Date : 1"/11/#00$ %ev!e& Date : 1$/11/#00'
*B+)C(%V) # The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh assura(ce that the a(alyt!cal ,ethod for assay of C!proflo-ac!( /00 Ta+let &!ll g!ve results &!th accepta+le Accuracy0 %epeat!+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( the .arc!p-/00 Ta+let* SC*P) #
degree of !( .arc!p1!(ear!ty0 appl!ed to
Th!s ,ethod appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of C!proflo-ac!(*
$)SP*NS%B%L%(,# 1* 3ual!ty Co(trol 4a(ager* #* Asstt* 3ual!ty Co(trol Che,!st* VAL%DA(%*N PA$AM)()$S# 1* 1!(ear!ty #* %epeat!+!l!ty* 5* %elat!ve .ta(dard Dev!at!o(* 6* %ugged(ess*

Prepared By
Total Page:
QC/VLD/01
0#-06
M)(-*D 1*
7e!ght accurately e8u!vale(t to a+out 100,g of C!proflo-ac!( &ork!(g %efere(ce sta(dard a(d !ts e8u!vale(t to test !( a 100,l volu,etr!c flask * D!ssolve &!th 0*1)9ydrochlor!c Ac!d a(d ,ake up to sa,e0 ,!- a(d f!lter !f re8u!red* 7!th a+ove d!lut!o( prepare sta(dard a(d sa,ple solut!o( of 100,cg/,l &!th 0*1) 9ydrochlor!c ac!d separately0 ,!- a(d ,ake ho,oge(eous solut!o(* P!pette 5,l0/,l0$,l0',l a(d 11,l of sta(dard a(d sa,ple solut!o( separately !( a cal!+rated /0,l*volu,etr!c flask* To each flask add 1,l of /:&;v solut!o( of A(hydrous <err!c chlor!de !( &ater* 4ake up &!th d!st!lled &ater to produced /0,l0 ,!- to ,ake ho,oge(eous solut!o(* 4easure the a+sor+a(ce at ,a-!,u, at a+out 65"(,0aga!(st &ater as +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of C!proflo-ac!( peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g C!proflo-ac!( solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
#* 5* 6* /* 6*
$* "* '*

Prepared By
Total Page:
QC/VLD/01
05-06
L%N)A$%(, S(.D, The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of C!proflo-ac!( !( .arc!p-/00 Ta+les shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard C!proflo-ac!( solut!o( of #0 ? 100,cg/,l co(ce(trat!o( 2 ra(ge 65"(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. Concentration o! Ci0ro!lo1acin in 1* #* 5* 6* /* #0,cg;,l 60,cg;,l 60,cg;,l "0,cg;,l 100,cg;,l c23 l Peak area 60/ 6/0 /5/ /$0 60/

Assay Method Validation Na e o! the Prod"ct#
Prepared By Date of Issue/ ffect!ve Date : 1"/11/#00$
Total Page:
QC/VLD/01
06-06
SA$C%P&'00 (ABL)(
Checked By/ Approved By %ev!e& Date : 1$/11/#00' %ev!s!o( )o* : 00
$)P)A(%B%L%(, S(.D, %epeat!+!l!ty of assay ,ethod of C!proflo-ac!( !( .arc!p-/00 Ta+les shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard C!proflo-ac!( solut!o( of 100,cg/,l co(ce(trat!o( 2 ra(ge 65"(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, Sr. No. 1 #* 5* 6* /* Concentration in 100,cg;,l 100,cg;,l 100,cg;,l 100,cg;,l 100,cg;,l c23 l Peak area 606 60" 605 60/ 606
Total Page:
0/-06

Prepared By
QC/VLD/01
$)LA(%V) S(ANDA$D D)V%A(%*N Test co(ce(trat!o( of C!proflo-ac!( used @ 100,cg;,l* )u,+er of test solut!o( used @ / 606A60"A605A60/A606 Average area @ ----------------------------------/ Dev* . @ @ 606*"
B606-606*"C# AB60"-606*"C# AB605-606*"C# AB60/-606*"C# AB606-606*"C# [ --------------------------------------------------------------------------------------] 1/# /-1 0*66A10*#6A5*#6A0*06A0*66 @ [--------------------------------------]1/# 6 16*" @ [ -------]1/# 6 @ [ 5*$] @ 1*'#5/ 1*'#5/ - 100 @ -----------------606*"
1/#
$SD 1!,!t
@ 0*51":
: B )ot ,ore tha( #*0: C

Total Page:
QC/VLD/01
06-06
SA$C%P&'00 (ABL)(
$.44)DN)SS S(.D, The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of C!proflo-ac!( !( .arc!p-/00 ta+let shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days*
$.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B%aE(!sh Fohl!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of .a,ple g,* 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 65"(, of sa,ple : of C!proflo-ac!(
A(alyst- II B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of .a,ple g, 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 65"(, of sa,ple : of C!proflo-ac!(
01 0# 05
0*116" 0*11/6 0*11/"
0*156" 0*15/# 0*156#
60# 60$ 60/
60" 61# 61/
100*11 ''*61 101*5/
0*116# 0*116/ 0*1166
0*156' 0*15/6 0*15/#
606 60' 61#
601 616 60"
''*65 101*1/ ''*//
Average &t of ta+let 6$0*# ,g 4ea( 100*5/: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : 100*# : .ta(dard Dev!at!o( : G10 :
Average&t*of ta+let 4ea( .ta(dard Dev!at!o(
6$/*1 ,g 100*06: 10:

Total Page:
QC/VLD/08
01-06
SA$/L*9&800 (ABL)(
P.$P*S) #&The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of Hflo-ac!( !( .arflok-#00 Ta+let &!ll g!ve results &!th accepta+le Accuracy0 1!(ear!ty0 %epeat!+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the .arflok-#00 Ta+let* SC*P)#& Th!s ,ethod appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of Hflo-ac!(*
$)SP*NS%B%L%(,# 1* 3ual!ty Co(trol 4a(ager* #* Asstt* 3ual!ty Co(trol Che,!st* VAL%DA(%*N PA$AM)()$S #& 1* 1!(ear!ty* #* %epeat!+!l!ty* 5* %elat!ve .ta(dard Dev!at!o(* 6* %ugged(ess*

Prepared By Date of Issue/ ffect!ve Date : 1"/11/#00$ M)(-*D 1*
Total Page:
QC/VLD/08
0#-06
SA$/L*9&800 (ABL)(
7e!gh accurately e8u!vale(t to a+out /0,g of Hflo-ac!( &ork!(g %efere(ce sta(dard a(d !ts e8u!vale(t to test !( a 100,l volu,etr!c flask * D!ssolve &!th 0*1)9ydrochlor!c Ac!d a(d ,ake up to sa,e0 ,!- a(d f!lter !f re8u!red* P!pette 5,l06,l0/,l06,l a(d $,l of sta(dard a(d sa,ple solut!o( separately !( a cal!+rated /0,l*volu,etr!c flask* To each flask add 1,l of /:&;v solut!o( of <err!c Chlor!de* 4ake up the volu,e &!th d!st!lled &ater to produce /0,l0 ,!- to ,ake ho,oge(eous solut!o(* 4easure the a+sor+a(ce at ,a-!,u, at a+out 65$(,0aga!(st &ater as +la(k a(d calculate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of Hflo-ac!( peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s *Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g Hflo-ac!( solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
#* 6* /* 6*
$* "* '*

Total Page:
QC/VLD/08
05-06
SA$/L*9&800 (ABL)(
L%N)A$%(, S(.D, The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of Hflo-ac!( !( .arflo--#00 Ta+les shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Hflo-ac!( solut!o( of 50 ? $0,cg/,l co(ce(trat!o( 2 ra(ge 65$(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. 1* #* 5* 6* /* Concentration o! *!lo1acin in 50,cg;,l 60,cg;,l /0,cg;,l 60,cg;,l $0,cg;,l c23 l Peak area 56" 65$ /1# /'1 666

Total Page:
QC/VLD/08
06-06
SA$/L*9&800 (ABL)(
$)P)A(%B%L%(, S(.D, %epeat!+!l!ty of assay ,ethod of Hflo-ac!( !( .arflo--#00 Ta+les shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Hflo-ac!( solut!o( of /0 ,cg/,l co(ce(trat!o( 2 ra(ge 65$(,*%epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, S.No. 1 #* 5* 6* /* Concentration in /0,cg;,l /0,cg;,l /0,cg;,l /0,cg;,l /0,cg;,l c23 l Peak area /1/ /1# /1/ /0' /1'
Total Page:
0/-06

Prepared By
QC/VLD/08
SA$/L*9&800 (ABL)(
Date of Issue/ ffect!ve Date : 1"/11/#00$
$)LA(%V) S(ANDA$D D)V%A(%*N Test co(ce(trat!o( of Hflo-ac!( used @ /0,cg;,l* )u,+er of test solut!o( used @ / /1/ A /1# A /1/ A /0' A /1' Average area @ -----------------------------------------/ @ /15*6
Dev* . @
B/1/-/15*6C# AB/1#-/15*6C# AB/1/-/15*6C# AB/0'-/15*6C# AB/1'-/15*6C# 1/# [ ---------------------------------------------------------------------------------------] /-1
#*/6A1*'6A1*'6A1'*56A51*56 @ [---------------------------------------]1/# 6 /$*# @ [ -------] 1/# 6 @ [ 16*5]

1/#
@ 5*$"1
$SD
5*$"1 - 100 @ -----------------/15*6
@ 0*$56:
1!,!t
Total Page:
06-06

Prepared By
QC/VLD/08
SA$/L*9&800 (ABL)(
Date of Issue/ ffect!ve Date : 1"/11/#00$
$.44)DN)SS S(.D, The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of Hflo-ac!( !( .arflok-#00 ta+let shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of .a,ple g,* 4easured 4easured A+sor+a(c A+sor+a(ce e at at 65$(, of %ef* of sa,ple .td* : of Hflo-ac!(
A(alyst- II B%aE(!sh Fohl!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of .a,ple g, 4easured A+sor+a(c e at of %ef* .td* 4easured A+sor+a(ce at 65$(, of sa,ple : of Hflo-ac!(
01 0# 05
0*06'" 0*0/01 0*0/1#
0*10#1 0*101' 0*10#'
/0' /11 /1'
/1# /1/ /1#
100*6$ 101*$ 100*$
0*06'' 0*0/1# 0*06"'
0*1006 0*101" 0*101#
/1# /06 /0"
/0/ /10 /16
'"*'$ 10#*'/ '"*'0
Average &t of ta+let 610*6 ,g 4ea( 101*0#: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : 100*6/ : .ta(dard Dev!at!o( : G10 :
606*6 ,g 100*#$: 10:

Assay Method Validation Na e o! the Prod"ct# SA$N%M&P (ABL)(
Total Page:
QC/VLD/0:
01-11
Prepared By Date of Issue/ ffect!ve Date : 1'/1#/#00$
Checked By/ Approved By %ev!e& Date : 1"/1#/#00' %ev!s!o( )o* : 00
P.$P*S) # The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of )!,esul!de 2 Paraceta,ol !( .ar(!,-P Ta+let &!ll g!ve results &!th accepta+le Accuracy0 1!(ear!ty0 %epeat!+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the .ar(!,-P Ta+let* SC*P) # Th!s ,ethod appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of Paraceta,ol 2 )!,esul!de* 1. 3ual!ty Co(trol 4a(ager* 8. Asstt* 3ual!ty Co(trol Che,!st* VAL%DA(%*N PA$AM)()$S# 1. 8. :. ;. 1!(ear!ty* %epeat!+!l!ty* %elat!ve .ta(dard Dev!at!o(* %ugged(ess*
$)SP*NS%B%L%(, #

Total Page:
QC/VLD/0:
0#-11
P$*C)D.$) </or Paraceta ol= 1*
7e!ght accurately e8u!vale(t to a+out 60,g of Paraceta,ol &ork!(g %efere(ce sta(dard a(d !ts e8u!vale(t to sa,ple !( a 100,l volu,etr!c flask * D!ssolve &!th #0,l of 9ydrochlor!c Ac!d 14 a(d d!gest for 50 ,!(utes0 the( ,ake up the volu,e 100,l &!th d!st!lled &ater* P!pette #,l05,l06,l0/,l a(d 6,l of sta(dard a(d sa,ple solut!o( separately !( a cal!+rated /0,l* ,easur!(g flask* To each flask add #,l of 10:&;v solut!o( of .od!u, )!trate 2 allo& to sta(d for / ,!(utes0 the( add #,l of 10: &/v solut!o( of A,,o(!u, .ulpha,ate* Aga!( allo& to sta(d for / to 6 ,!(utes (o& further add # ,l* of 10:&/v solut!o( of .od!u, 9ydro-!de a(d keep !t for / ,!(utes* )o& adEust the volu,e to /0,l &!th d!st!lled &ater* 4easure the a+sor+a(ce at ,a-!,u, at a+out 6/0(,0 aga!(st &ater as +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of Paraceta,ol peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s *Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g Paraceta,ol solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
#* 5*
6*
/*
6* $* "*

Total Page:
QC/VLD/0:
05-11
L%N)A$%(, S(.D, The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of Paraceta,ol !( .ar(!,-P Ta+les shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard .ar(!,-P solut!o( of #6 ? $#,cg/,l co(ce(trat!o( 2 ra(ge 6/0(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. 1* #* 5* 6* /* Concentration o! Paraceta ol in #6,cg;,l 56,cg;,l 6",cg;,l 60,cg;,l $#,cg;,l c23 l Peak area /#/ /'/ 66/ 6'/ $6#

Total Page:
QC/VLD/0:
06-11
$)P)A(%B%L%(, S(.D, %epeat!+!l!ty of assay ,ethod of Paraceta,ol !( .ar(!,-P Ta+les shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard .ar(!,-P solut!o( of #6 ,cg/,l co(ce(trat!o( 2 ra(ge 6/0(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(B%L%(, Sr.No. 1 #* 5* 6* /* Concentration in #6,cg;,l #6,cg;,l #6,cg;,l #6,cg;,l #6,cg;,l c23 l Peak area /#/ /#" /#$ /#6 /#/

Total Page:
QC/VLD/0:
0/-11
$)LA(%V) S(ANDA$D D)V%A(%*N Test co(ce(trat!o( of Paraceta,ol used @ #6,cg;,l* )u,+er of test solut!o( used @ / /#/ A /#" A /#$ A /#6 A /#/ Average area @ -----------------------------------------/ @ /#6*#
Dev* . @
B/#/-/#6*#C# AB/#"-/#6*#C# AB/#$-/#6*#C# AB/#6-/#6*#C# AB/#/-/#6-#C# 1/# [ ---------------------------------------------------------------------------------------] /-1
1*66A5*#6 A0*66A0*06A1*66 @ [---------------------------------------]1/# 6 6*" @ [ -------]1/# 6 @ [ 1*$]

1/#
1*505
$SD
1*505 - 100 @ -----------------/#6*#
@ 0*#6$$:
1!,!t

Total Page:
QC/VLD/0:
06-11
$.44)DN)SS S(.D, The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of Paraceta,ol !( .ar(!,-P ta+let shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of .a,ple g,* 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 6/0(, of sa,ple : of Paraceta ,ol-,ol
7t* of %ef* .ta(dard g,* 7t* of .a,ple g, 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 6/0(, of sa,ple : of Paraceta,ol
01 0# 05
0*0/'" 0*0601 0*0/'#
0*0$"6 0*0$'# 0*0$"6
/#1 /5# /1"
/#" /#" /#/
100*"5 '"*#5 ''*1'
0*060# 0*0/'# 0*061#
0*0$"# 0*0$$' 0*0$'1
/1# /1' /##
/1" /1/ /#/
101*'' '"*$/ 101*'
Average &t of ta+let 6/#*# ,g 4ea( ''*61: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : 100*1/ : .ta(dard Dev!at!o( : G10 :
6/6*" ,g 100*"": 10:

Total Page:
QC/VLD/0:
0$-11
SA$N%M&P (ABL)(
P$*C)D.$) </or Ni es"lide= 1*
7e!ght accurately e8u!vale(t to a+out /0,g of )!,esul!de &ork!(g %efere(ce sta(dard a(d !ts e8u!vale(t to sa,ple !( a 100,l volu,etr!c flask * D!ssolve &!th 50 to 60,l of 0*14 solut!o( of .od!u, 9ydro-!de* D!gest +oth the solut!o( for 10 ,!(utes the( ,ake up the volu,e to 100,l &!th 0*14 solut!o( of .od!u, 9ydro-!de* P!pette #,l05,l06,l0/,l a(d 6,l of sta(dard a(d sa,ple solut!o( separately !( a cal!+rated /0,l*,easur!(g flask* To each flask add #0,l 0*14 .od!u, 9ydro-!de solut!o( shake &ell a(d further adEust the volu,e up to /0,l &!th 0*14 solut!o( of .od!u, 9ydro-!de* 4easure the a+sor+a(ce of +oth the solut!o( at 60/(,0 aga!(st 0*14 .od!u, 9ydro-!de solut!o( as +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of )!,esul!de peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s *Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g )!,esul!de solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
#* 5* 6* /*
6* $* "*

Total Page:
QC/VLD/0:
0"-11
SA$N%M&P (ABL)(
L%N)A$%(, S(.D, The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of )!,esul!de !( .ar(!,-P Ta+lets shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard )!,esul!de solut!o( of #0 ? 60,cg/,l co(ce(trat!o( 2 ra(ge 60/(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. 1* #* 5* 6* /* Concentration o! Ni es"lide in #0,cg;,l 50,cg;,l 60,cg;,l /0,cg;,l 60,cg;,l c23 l Peak area //# /'/ 65/ $0# $/$

Total Page:
QC/VLD/0:
0'-11
SA$N%M&P (ABL)(
$)P)A(B%L%(, S(.D, %epeat!+!l!ty assay ,ethod of )!,esul!de !( .ar(!,-P Ta+lets shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard )!,esul!de solut!o( of #0 ,cg/,l co(ce(trat!o( 2 ra(ge 60/(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, Sr.No. 1 #* 5* 6* /* Concentration in #0,cg;,l #0,cg;,l #0,cg;,l #0,cg;,l #0,cg;,l c23 l Peak area //' /61 /61 /60 /65

Total Page:
QC/VLD/0:
10-11
SA$N%M&P (ABL)(
$)LA(%V) S(ANDA$D D)V%A(%*N
Test co(ce(trat!o( of )!,esul!de used @ #0,cg;,l* )u,+er of test solut!o( used @ / //' A /61 A /61 A /60 A /65 Average area @ -----------------------------------------/ @ /60*"
Dev* . @
B//'-/60*"C# AB/61-/60*"C# AB/61-/60*"C# AB/60-/60*"C# AB/65-/60*"C# 1/# [ ---------------------------------------------------------------------------------------] /-1
5*#6A0*06 A0*06A0*66A6*"6 @ [---------------------------------------]1/# 6 "*" @ [ -------]1/# 6 @ [ #*#] $SD

1/#
1*616#
1*616# - 100 @ -----------------/60*" :
@ 0*#/#1:
1!,!t
B )ot ,ore tha( #*0: C

Prepared By
Total Page:
QC/VLD/0:
11-11
SA$N%M&P (ABL)(
Checked By/ Approved By
Date of Issue/ ffect!ve Date : 1'/1#/#00$
%ev!e& Date : 1"/1#/#00'
%ev!s!o( )o* : 00
$.44)DN)SS S(.D, The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of )!,esul!de !( .ar(!,-P ta+let shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B%aE(!sh Fohl!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of .a,ple g,* 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 60/(, of sa,ple : of )!,esul! de
7t* of %ef* .ta(dard g,* 7t* of .a,ple g, 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 60/(, of sa,ple : of )!,esul! de
01 0# 05
0*06'' 0*06"' 0*0/01
0*5#/" 0*5#/1 0*5#/1
/60 /6# /60
/6" /6/ ///
101*51 '"*66 ''*61
0*06'" 0*06'6 0*0/0#
0*5#61 0*5#6' 0*5#/1
/6/ //' //5
/60 /6# //6
''*11 ''*"" 101*6/
Average &t of ta+let 6/#*# ,g 4ea( ''*"/: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : 100*05 : .ta(dard Dev!at!o( : G10 :
6/6*" ,g 100*#1: 10:

Prepared By Date of Issue/ ffect!ve Date : #"/11/#00$
Total Page:
QC/VLD/0;
01-06
SA$/%>&100 D( (ABL)(
Checked By/ Approved By %ev!e& Date : #$/11/#00' %ev!s!o( )o* : 00
P.$P*S) #& The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of Cef!-!,e Tr!hydrate !( .arf!-100 DT Ta+let &!ll g!ve results &!th accepta+le Accuracy0 1!(ear!ty0 %epeata+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the .arf!--100 DT Ta+let* SC*P)#& Th!s ,ethod appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of Cef!-!,e Tr!hydrate*
$)SP*NS%B%L%(,# 1* 3ual!ty Co(trol 4a(ager* #* Asstt* 3ual!ty Co(trol Che,!st* VAL%DA(%*N PA$AM)()$S #& 1* 1!(ear!ty* #* %epeat!+!l!ty* 5* %elat!ve .ta(dard Dev!at!o(* 6* %ugged(ess*

Total Page:
QC/VLD/0;
0#-06
SA$/%>&100 D( (ABL)(
M)(-*D 1* 7e!gh accurately e8u!vale(t to a+out 100,g of Cef!-!,e &ork!(g %efere(ce sta(dard a(d !ts e8u!vale(t to test !( a 100,l volu,etr!c flask * D!ssolve &!th 4etha(ol a(d ,ake up to volu,e up to 100,l* P!pette 1,l0#,l05,l06,l a(d /,l of sta(dard a(d sa,ple solut!o( separately !( a cal!+rated 100,l*volu,etr!c flask* To each flask add 4etha(ol a(d ,ake up the volu,e up to 100,l* 4easure the a+sor+a(ce at ,a-!,u, at a+out #6"(,0aga!(st 4etha(ol as +la(k a(d calculate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of Cef!-!,e peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s *Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g Cef!-!,e solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
#* 5* 6* /*
6* $* "*

Total Page:
QC/VLD/0;
05-06
SA$/%>&100 D( (ABL)(
L%N)A$%(, S(.D, The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of Cef!-!,e Tr!hydrate !( .arf!--100 DT Ta+lets shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Cef!-!,e Tr!hydrate solut!o( of #0 ? /0,cg/,l co(ce(trat!o( 2 ra(ge #6"(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. 1* #* 5* 6* /* Concentration o! Ce!i1i e in 10,cg;,l #0,cg;,l 50,cg;,l 60,cg;,l /0,cg;,l c23 l Peak area 6'/ /1/ /60 /$0 /'/

Total Page:
QC/VLD/0;
06-06
SA$/%>&100 D( (ABL)(
$)P)A(%B%L%(, S(.D,
%epeat!+!l!ty of assay ,ethod of Cef!-!,e Tr!hydrate !( .arf!--100 DT Ta+lets shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Cef!-!,e Tr!hydrate solut!o( of 10,cg/,l co(ce(trat!o( 2 ra(ge #6"(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o( *BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, S.No. 1 #* 5* 6* /* Concentration in 10,cg;,l 10,cg;,l 10,cg;,l 10,cg;,l 10,cg;,l c23 l Peak area 6'/ 6'# 6'$ 6'/ 6'6

Total Page:
QC/VLD/0;
0/-06
SA$/%>&100 D( (ABL)(
$)LA(%V) S(ANDA$D D)V%A(%*N Test co(ce(trat!o( of Cef!-!,e used @ 10,cg;,l* )u,+er of test solut!o( used @ / 6'/ A 6'# A 6'$ A 6'/ A 6'6 Average area @ -----------------------------------------/
@ 6'/
Dev* . @
B6'/-6'/C# AB6'/-6'#C# AB6'/-6'$C# AB6'/-6'/C# AB6'/-6'6C# [ --------------------------------------------------------------------------] /-1
1/#
0A'A6A0A1 @ [---------------------------------------]1/# 6 16 @ [ -------] 1/# 6 @ [ 5*/] @ 1*"$0" 1*"$0" - 100 @ -----------------6'/

1/#
$SD
@ 0*5$$:
1!,!t

Total Page:
QC/VLD/0;
06-06
SA$/%>&100 D( (ABL)(
$.44)DN)SS S(.D,
The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of Cef!-!,e Tr!hydrate !( .arf!--100 DT Ta+let shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of .a,ple g,* 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at #6"(, of sa,ple : of Cef!-!,e
7t* of %ef* .ta(dard g,* 7t* of .a,ple g, 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at #6"(, of sa,ple : of Cef!-!,e
01 0# 05
0*11#" 0*111' 0*1151
0*601' 0*60#1 0*601#
6'" 6'# 6'"
/0# 6'' 6""
101*$/ 101*/0 ''*56
0*111" 0*11#' 0*11#/
0*60#" 0*6051 0*60##
/0# 6'' 6'#
/0" /0/ 6'"
101*#1 10#*16 10#*0#
Average &t of ta+let 60#*" ,g 4ea( 100*"6: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : 101*5# : .ta(dard Dev!at!o( : G10 :
605*6 ,g 101*$': 10:

Prepared By Date of Issue/ ffect!ve Date : 10/10/#00$
Total Page:
QC/VLD/0'
01-06
SA$M*>&'00 CAPS.L)
Checked By/ Approved By %ev!e& Date : 0'/10/#00' %ev!s!o( )o* : 00
P.$P*S)#
The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of A,o-yc!ll!( !( .ar,o--/00 Capsule &!ll g!ve results &!th accepta+le Accuracy0 1!(ear!ty0 %epeat!+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the .ar,o--/00 Capsule*
SC*P) #
Th!s ,ethod !s appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of A,o-yc!ll!(*
$)SP*NS%B%L%(,# 1* 3ual!ty Co(trol 4a(ager* #* Asstt* 3ual!ty Co(trol Che,!st*
VAL%DA(%*N PA$AM)()$S# 1* 1!(ear!ty* #* %epeata+!l!ty* 5* %elat!ve .ta(dard Dev!at!o(* 6* %ugged(ess*

Prepared By Date of Issue/ ffect!ve Date : 10/10/#00$ M)(-*D 1* #
Total Page:
QC/VLD/0'
0#-06
SA$M*>&'00 CAPS.L)
7e!ght accurately 100,g %efere(ce sta(dard a(d e8u!vale(t to 100,g* A,o-yc!ll!( as test sa,ple* Bo&l !t &!th #0 to 50,l of d!st!lled &ater a(d ,ake up to produce 100,l*
#* 5* 6* /*
P!pette #,l0 5,l0 6,l0 /,l a(d 6,l of sta(dard a(d sa,ple solut!o( separately !( a cal!+rated /0,l*volu,etr!c flask* I( a /0,l volu,etr!c flask p!pette #,l %efere(ce a(d test solut!o( separately* To each flask add #,l of Phosphate +uffer p9 '*# a(d add 1,l I!ta,!( B6 dye** 4easure the a+sor+a(ce &!thout delay at ,a-!,u, at a+out 60/(,0aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of A,o-yc!ll!( peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g A,o-yc!ll!( solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
6* $* "*

Total Page:
QC/VLD/0'
05-06
SA$M*>&'00 CAPS.L)
L%N)A$%(, S(.D, The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge*
1!(ear!ty of assay ,ethod of A,o-yc!ll!( !( .ar,o--/00 Capsule shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard A,o-yc!ll!( solut!o( of 60 ? 1#0,cg/,l co(ce(trat!o( 2 ra(ge 60/(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. Concentration o! A o1ycillin in 1* #* 5* 6* /* 60,cg;,l 60,cg;,l "0,cg;,l 100,cg;,l 1#0,cg;,l c2/ l Peak area o! 6/# 6'/ $#" $6/ "0/

Total Page:
QC/VLD/0'
06-06
SA$M*>&'00 CAPS.L)
$)P)A(%B%L%(, S(.D,
%epeat!+!l!ty of assay ,ethod of A,o-yc!ll!( !( .ar,o--/00 Capsule shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard A,o-yc!ll!( solut!o( of 60,cg/,l co(ce(trat!o( 2 ra(ge 60/(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(B%L%(, Sr.No. 1 #* 5* 6* /* Concentration in 60,cg;,l 60,cg;,l 60,cg;,l 60,cg;,l 60,cg;,l c23 l Peak area 6/1 6/5 6/# 6/$ 6/1

Total Page:
QC/VLD/0'
0/-06
SA$M*>&'00 CAPS.L)
Test co(ce(trat!o( of A,o-yc!ll!( used @ 60,cg;,l* )u,+er of test solut!o( used @ / 6/1A6/5A6/#A6/$A6/1 Average area @ ----------------------------------/ Dev* . @
@ 6/#*"
B6/1-6/#*"C# AB6/5-6/#*"C# AB6/#-6/#*"C# AB6/$-6/#*"C# AB6/1-6/#*"C# [ -------------------------------------------------------------------------------------] 1/# /-1 5*#6A0*06A0*66A1$*66A5*#6 @ [-------------------------------------]1/# 6 #6*" @ [ -------]1/# 6 @ [ 6*# ] @ #*6"' #*6"' - 100 @ -----------------6/#*"
1/#
$SD
@ 0*5"1:
1!,!t

Total Page:
QC/VLD/0'
06-06
SA$M*>&'00 CAPS.L)
$.44)DN)SS S(.D,
The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of A,o-yc!ll!( !( .ar,o--/00 Capsule shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of .a,ple g,* 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 60/(, of sa,ple : of A,o-yc! -ll!(
7t* of %ef* .ta(dard g,* 7t* of .a,ple g, 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 60/(, of sa,ple : of A,o-yc!l -l!(
01 0# 05
0*116# 0*11/' 0*116/
0*116" 0*116# 0*11//
6// 6/6 6/5
6/# 6/" 6/$
100*$' 100*5" 101*/1
0*11/6 0*116# 0*11/#
0*116" 0*116' 0*116#
6/' 6/# 6/6
6// 66# 6/0
'"*/$ 101*50 '"*60
Average f!ll &e!ght /"0*# ,g 4ea( 100*"': .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : 100*1' : .ta(dard Dev!at!o( : G10 :
Average f!ll &e!ght 4ea( .ta(dard Dev!at!o(
/"#*# ,g ''*6': 10:

Prepared By Date of Issue/ ffect!ve Date :#$/0'/#00$
Total Page:
QC/VLD/0?
01-06
AC%4*N) CAPS.L)
Checked By/ Approved By %ev!e& Date : #6/0'/#00' %ev!s!o( )o* : 00
P.$P*S)#
The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of H,epraDole !( Ac!go(e Capsule &!ll g!ve results &!th accepta+le Accuracy0 1!(ear!ty0 %epeata+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the Ac!go(e Capsule*
SC*P) #
Th!s ,ethod !s appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of H,epraDole*
$)SP*NS%B%L%(,# 1* 3ual!ty Co(trol 4a(ager* #* Asstt* 3ual!ty Co(trol Che,!st* VAL%DA(%*N PA$AM)()$S# 1* 1!(ear!ty* #* %epeata+!l!ty* 5* %elat!ve .ta(dard Dev!at!o(* 6* %ugged(ess*

Prepared By Date of Issue/ ffect!ve Date :#$/0'/#00$ M)(-*D 1* #
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AC%4*N) CAPS.L)
7e!ght accurately #0,g %efere(ce sta(dard a(d e8u!vale(t to #0,g* H,epraDole as test sa,ple* D!ssolve !t &!th #0 to 50,l of 0*14 .od!u, 9ydro-!de solut!o( shake v!gorously 6-/ ,!(utes a(d ,ake up the volu,e up to /0,l &!th 0*14 )aH9 solut!o(*
#* 5* 6* /*
P!pette 1,l0 #,l0 5,l0 6,l a(d /,l of sta(dard a(d sa,ple solut!o( separately !( a cal!+rated /0,l*volu,etr!c flask* I( a /0,l volu,etr!c flask p!pette 1,l %efere(ce a(d test solut!o( separately a(d ,ake up the volu,e up to /0,l* &!th 0*14 .od!u, 9ydro-!de solut!o(* 4easure the a+sor+a(ce &!thout delay at ,a-!,u, at a+out #6"(,0aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of H,epraDole peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g H,epraDole solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
6* $* "*

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AC%4*N) CAPS.L)
1!(ear!ty of assay ,ethod of H,epraDole !( Ac!go(e Capsule shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard H,epraDole solut!o( of " ? 60,cg/,l co(ce(trat!o( 2 ra(ge #6"(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. Concentration o! A o1ycillin in 1* #* 5* 6* /* ",cg;,l 16,cg;,l #6,cg;,l 5#,cg;,l 60,cg;,l c23 l Peak area o! 5'$ 6#1 6'/ /6/ 60/

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AC%4*N) CAPS.L)
$)P)A(%B%L%(, S(.D,
%epeat!+!l!ty of assay ,ethod of H,epraDole !( Ac!go(e Capsule shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard H,epraDole solut!o( of " ,cg/,l co(ce(trat!o( 2 ra(ge #6"(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(,
Sr.No. 1 #* 5* 6* /*
Concentration in ",cg;,l ",cg;,l ",cg;,l ",cg;,l ",cg;,l
c23 l
Peak area 5'" 601 5'$ 5'' 5'"

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AC%4*N) CAPS.L)
Test co(ce(trat!o( of A,o-yc!ll!( used @ ",cg;,l* )u,+er of test solut!o( used @ / 5'"A601A5'$A5''A5'" Average area @ ----------------------------------/ Dev* . @
@ 5'"*6
B5'"-5'"*6C# AB601-5'"*6C# AB5'$-5'"*6C# AB5''-5'"*6C# AB5'"-5'"*6C# [ ---------------------------------------------------------------------------------------] 1/# /-1 0*56A/*$6 A#*/6A0*16A0*56 @ [---------------------------------------]1/# 6 '*# @ [ -------]1/# 6 @ [ #*5 ] @ 1*/16/
1/#
$SD
1*/16/ - 100 @ -----------------5'"*6
@ 0*5"06:
1!,!t

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AC%4*N) CAPS.L)
$.44)DN)SS S(.D,
The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of H,epraDole !( Ac!go(e Capsule shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of .a,ple g,* 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at #6"(, of sa,ple : of H,epraD -ole
7t* of %ef* .ta(dard g,* 7t* of .a,ple g, 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at #6"(, of sa,ple : of H,epraDole
01 0# 05
0*#6/$ 0*#6$5 0*#661
0*#'60 0*#'#$ 0*#'5'
5'/ 601 5'5
5'' 5'6 5'6
100*60 ''*#0 100*5"
0*#6$# 0*#6/$ 0*#6$5
0*#'#6 0*#'61 0*#'#6
605 5'" 5'6
5'' 601 5'5
''*6" ''*6$ ''*$/
Average f!ll &e!ght #'5*6 ,g 4ea( ''*'': .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : ''*$" .ta(dard Dev!at!o( : G10:
Average f!ll &e!ght 4ea( .ta(dard Dev!at!o(
#'5*6 ,g ''*/$: 10:

Prepared By Date of Issue/ ffect!ve Date : #'/10/#00$
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SA$M*> D$, S,$.P

Checked By/ Approved By %ev!e& Date : #"/10/#00' %ev!s!o( )o* : 00
P.$P*S)#
The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of A,o-yc!ll!( !( .ar,o- Dry .yrup &!ll g!ve results &!th accepta+le Accuracy0 1!(ear!ty0 %epeata+!l!ty0
%elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the .ar,o- Dry .yrup* SC*P) # Th!s ,ethod !s appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of A,o-yc!ll!(*
$)SP*NS%B%L%(,# 1* 3ual!ty Co(trol 4a(ager* #* Asstt* 3ual!ty Co(trol Che,!st* VAL%DA(%*N PA$AM)()$S# 1* 1!(ear!ty* #* %epeat!+!l!ty* 5* %elat!ve .ta(dard Dev!at!o(* 6* %ugged(ess*

Prepared By Date of Issue/ ffect!ve Date : #'/10/#00$ M)(-*D 1* #
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SA$M*> D$, S,$.P

7e!ght accurately 100,g %efere(ce sta(dard a(d e8u!vale(t to 100,g* A,o-yc!ll!( as test sa,ple* Bo&l !t &!th #0 to 50,l of d!st!lled &ater a(d ,ake up to produce 100,l*
#* 5*
P!pette #,l0 6,l0 /,l0 6,l a(d $,l of sta(dard a(d sa,ple solut!o( separately !( a cal!+rated /0,l*volu,etr!c flask* I( a /0,l volu,etr!c flask p!pette #,l %efere(ce a(d test solut!o( separately* To each flask add #,l of Phosphate +uffer p9 '*# a(d add 1,l I!ta,!( B6 dye* A(d ,ake up the volu,e up to /0,l &!th &ater* 4easure the a+sor+a(ce &!thout delay at ,a-!,u, at a+out 60/(,0aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of A,o-yc!ll!( peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g A,o-yc!ll!( solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
6* /*
6* $* "*

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SA$M*> D$, S,$.P

L%N)A$%(, S(.D,
The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of A,o-yc!ll!( !( .ar,o- Dry .yrup shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard A,o-yc!ll!( !( solut!o( of 60 ? 1#0,cg/,l co(ce(trat!o( 2 ra(ge 60/(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. Concentration o! A o1ycillin in 1* #* 5* 6* /* 60,cg;,l 60,cg;,l "0,cg;,l 100,cg;,l 1#0,cg;,l c23 l Peak area o! 6/1 6'/ $#6 $$/ "06

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SA$M*> D$, S,$.P

$)P)A(%B%L%(, S(.D,
%epeat!+!l!ty of assay ,ethod of A,o-yc!ll!( !( .ar,o- Dry .yrup shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard A,o-yc!ll!( !( solut!o( of 60 ,cg/,l co(ce(trat!o( 2 ra(ge 60/(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, Sr.No. 1 #* 5* 6* /* Concentration in 60,cg;,l 60,cg;,l 60,cg;,l 60,cg;,l 60,cg;,l c23 l Peak area 6/1 6/# 6/$ 660 6//

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SA$M*> D$, S,$.P

Test co(ce(trat!o( of A,o-yc!ll!( used @ 60,cg;,l* )u,+er of test solut!o( used @ / 6/1A6/#A6/$A660A6// Average area @ ----------------------------------/ Dev* . @
@ 6//
B6/1-6//C# AB6/#-6//C# AB6/$-6//C# AB660-6//C# AB6//-6//C# [ ------------------------------------------------------------------------------] 1/# /-1 16A 'A 6 A #/ A 0 @ [---------------------------------------]1/# 6 /6 @ [ -------]1/# 6 @ [ 15*/ ] @ 5*6$6# 5*6$6# - 100 @ -----------------6// : B )ot ,ore tha( #*0: C
1/#
$SD 1!,!t
@ 0*/60:

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SA$M*> D$, S,$.P

$.44)DN)SS S(.D,
The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of A,o-yc!ll!( !( .ar,o- Dry .yrup shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of 4easure .a,ple d ,l A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 60/(, of sa,ple : of A,o-yc!ll!(
7t* of %ef* .ta(dard g,* 7t* of .a,ple ,l 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 60/(, of sa,ple : of A,o-yc!ll!(
01 0# 05
0*1161 0*116" 0*11//
6,l 6,l 6,l
6/5 6/" 6/#
6/6 66/ 6/6
100*/6 101*$6 100*"#
0*11/' 0*116# 0*11//
6,l 6,l 6,l
6/$ 6/' 6/$
6/# 665 6/6
''*1/ 100*1" ''*11
1a+el Cla!, 4ea( .ta(dard Dev!at!o(
1#/,g A,o-yc!ll!(/ /,l 100*"#: 10:
1#/,g A,o-yc!ll!(/ /,l
100*01: 10:
Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : 100*61 : .ta(dard Dev!at!o( : G10 :

Prepared By Date of Issue/ ffect!ve Date : 1$/01/#00"
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01-06
C)/SA$&18' D$, S,$.P

Checked By/ Approved By %ev!e& Date : 16/01/#010 %ev!s!o( )o* : 00
P.$P*S) # The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of Cephale-!( !( Cefasar-1#/ Dry .yrup &!ll g!ve results &!th accepta+le Accuracy0 1!(ear!ty0 %epeat!+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the Cefasar-1#/ Dry .yrup* SC*P) # Th!s ,ethod !s appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of Cephale-!(*
$)SP*NS%B%L%(,# 1* 3ual!ty Co(trol 4a(ager* #* Asstt* 3ual!ty Co(trol Che,!st* VAL%DA(%*N PA$AM)()$S# 1* 1!(ear!tyJ #* %epeat!+!l!ty* 5* %elat!ve .ta(dard Dev!at!o(* 6* %ugged(ess*

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C)/SA$&18' D$, S,$.P

M)(-*D 1*
7e!ght accurately e8u!vale(t #/0,g of Cephale-!( a(d d!ssolve !( #0,l of )eutral 4etha(ol a(d t!trate &!th 0*14 .od!u, 9ydro-!de us!(g Bro,o,ethyl +lue as !(d!cator0 perfor, a +la(k for (ecessary correct!o(* ach ,l* of 0*14 .od!u, 9ydro-!de !s e8u!vale(t to 0*056$6g,* of Cephale-!(* 7e!ght #/0,g0 500,g0 5/0,g*0 600,g* 2 6/0,g* Cephale-!( !( #0,l* of )eutral 4etha(ol 2 t!trate &!th 0*14 )aH9 us!(g Bro,o,ethyl +lue as !(d!cator* ach ,l* of 0*1, .od!u, 9ydro-!de !s e8u!vale(t to 0*056$6g,* of Cephale-!(* )ote the volu,e co(su,ed 2 ta+ulate the o+served data !( o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of Cephale-!( peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g Cephale-!( solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y calculat!o( volu,e co(su,ed +y the Cephale-!(*
#*
5* 6*
/* 6* $*

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C)/SA$&18' D$, S,$.P

L%N)A$%(, S(.D, The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of Cephale-!( !( Cefsar-1#/ Dry .yrup shall +e stud!ed +y #/0,gto 6/0 ,g Cephale-!(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, B 4olar!ty of 0*14 )aH9 !s 0*10#50/C Sr.No. 1* #* 5* 6* /* Aei2ht o! Ce0hale1in in #/0,g* 500,g* 5/0,g* 600,g* 6/0,g* 2 Vol" e cons" ed $,l "*6,l '*$,l 11*#,l 1#*$,l

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C)/SA$&18' D$, S,$.P

$)P)A(%B%L%(, S(.D,
%epeat!+!l!ty of assay ,ethod of Cephale-!( !( Cefsar-1#/ Dry .yrup shall +e stud!ed +y #/0 ,g Cephale-!(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, B 4olar!ty of 0*14 )aH9 !s 0*10#50/C Sr.No. 1 #* 5* 6* /* Aei2ht o! Ce0hale1in #/0,g* #/0,g* #/0,g* #/0,g* #/0,g* Vol" e cons" ed $,l 6*',l $*1,l $*#,l 6*',l

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C)/SA$&18' D$, S,$.P

$)LA(%V) S(ANDA$D D)V%A(%*N Test co(ce(trat!o( of Cephale-!( used @ #/0,g* )u,+er of test solut!o( used @ / $A6*'A$*1A$*#A6*' Average volu,e @ ----------------------------------/ @ $*0#
Dev* . @
B$- $*0#C# AB6*'-$*0#C# AB$*1-$*0#C# AB$*#-$*0#C# AB6*'-$*0#C# [ ---------------------------------------------------------------------------------------] 1/# /-1 0*0006A0*0166A0*0066A0*05#6A0*0166 @ [------------------------------------------------------]1/# 6 0*06" @ [ -------] 1/# 6 @ [ 0*01$ ] @ 0*150 0*150 - 100 @ -----------------$*0#
1/#
$SD
@ 1*"/$:
1!,!t

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C)/SA$&18' D$, S,$.P

$.44)DN)SS S(.D, The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of Cephale-!( !(Cefsar-1#/ Dry .yrup shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : B"rette '0 l <Borosil= 1ocat!o( : Che ical La7.
7t* of .a,ple 4olar!ty of 0*14 )aH9 <!(al Iolu,e used Assay
A(alyst- II B%aE(!sh Fohl!C Date of a(alys!s : I(stru,e(t 2 4odel : B"rette '0 l <Borosil= 1ocat!o( : Che ical La7.
7t* of .a,ple 4olar!ty of 0*14 )aH9 <!(al Iolu,e used Assay
01 0# 05
10,l 10,l 10,l
0*10#50/ 0*10#50/ 0*10#50/
$*0,l 6*',l $*0,l
''*/1 '"*0' ''*/1
10,l 10,l 10,l
0*10#50/ 0*10#50/ 0*10#50/
$*1,l $*0,l $*0,l
100*'6 ''*/1 ''*/#
1a+el Cla!, 1#/,g Cephale-!(//,l 1a+el Cla!, 4ea( ''*06: 4ea( .ta(dard Dev!at!o( 10: .ta(dard Dev!at!o( Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : ''*/#: .ta(dard Dev!at!o( : G10:
1#/,g Cephale-!(//,l ''*'': 10:

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C-L*$()> M*.(- AASChecked By/ Approved By %ev!e& Date : 0'/01/#010 %ev!s!o( )o* : 00
P.$P*S) # The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of Chlorhe-!d!(e Kluco(ate !(
Chlorte- 4outh 7ash &!ll g!ve results &!th accepta+le Accuracy0 1!(ear!ty0 %epeata+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the Cefasar-1#/ Dry .yrup* SC*P) # Th!s ,ethod !s appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of Chlorhe-!d!(e Kluco(ate*

Prepared By Date of Issue/ ffect!ve Date : 10/01/#00" M)(-*D #
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0#-0/
1* #* 5*
7e!gh accurately e8u!vale(t of #00,g* of sta(dard a(d d!ssolve !( 100,l of d!st!ll &ater*
Chlorhe-!d!(e Kluco(ate %efere(ce
<urther p!pette /,l0 10,l0 1/,l0 #0,l 2 #/,l of sta(dard a(d d!lute to 100,l* &!th &ater* 7e!gh accurately e8u!vale(t to /,g*0 10,g*0 1/,g*0 #0,g* 2 #/,g* of sa,ple0 +as!f!ed &!th 104 )aH9 a(d e-tracted &!th Chlorofor, B# - #0,lC* Co,+!(e Chlorofor, layer a(d d!lute to /0,l &!th &ater* <urther prepare d!lut!o( of /0,cg / ,l* &!th &ater* To 1 ,l* of each a+ove sta(dard a(d sa,ple d!lut!o(s add 5,l of dye solut!o( a(d /,l* of Chlorofor,* .hake &ell for 5 to 6 ,!(utes* 4easure the a+sor+a(ce &!thout delay at ,a-!,u, at a+out 610(,0 aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of Chlorhe-!d!(e Kluco(ate peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g Chlorhe-!d!(e Kluco(ate solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
6* /* 6*
$* "* '*

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QC/VLD/0B
05-0/
L%N)A$%(, S(.D,
The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of Chlorhe-!d!(e Kluco(ate !( Chlorte- 4outh&ash shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Chlorhe-!d!(e Kluco(ate !( solut!o( of 100 ? /00,cg/,l co(ce(trat!o( 2 ra(ge 610(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. Concentration o! Chlorhe1idine 4l"conate in 1* #* 5* 6* /* 100,cg;,l #00,cg;,l 500,cg;,l 600,cg;,l /00,cg;,l c23 l Peak area o! /66 66# $#6 $'1 "0/

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06-06
$)P)A(%B%L%(, S(.D,
%epeat!+!l!ty of assay ,ethod of Chlorhe-!d!(e Kluco(ate !( Chlorte- 4outh&ash shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Chlorhe-!d!(e Kluco(ate !( solut!o( of 100 ,cg/,l co(ce(trat!o( 2 ra(ge 610(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o( *BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, Sr.No. 1 #* 5* 6* /* Concentration in 100,cg;,l 100,cg;,l 100,cg;,l 100,cg;,l 100,cg;,l c23 l Peak area /66 /6/ /6" /6' /66

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QC/VLD/0B
0/-06
Test co(ce(trat!o( of Chlorhe-!d!(e Kluco(ate used @ 100,cg;,l* )u,+er of test solut!o( used @ / /66A/6/A/6"A/6'A/66 Average area @ ----------------------------------/ @ /66*6
Dev* . @
B/66-/66*6C# AB/6/-/66*6C# AB/6"-/66*6C# AB/6'-/66*6C# AB/66-/66*6C# [ ---------------------------------------------------------------------------------------] 1/# /-1 /*$6A#*00/A5*# A1*'' A0*" @ [---------------------------------------]1/# 6 15*$// @ [ ----- ----]1/# 6 @ [ 5*65' ] 1/#
@ 1*"/6 $SD 1*"/6 - 100 @ -----------------/66*6 @ 0*55' :
1!,!t

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QC/VLD/0B
06-06
$.44)DN)SS S(.D,
The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of Chlorhe-!d!(e Kluco(ate !( Chlorte- 4outh&ash shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B%aE(!sh Fohl!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of 4easure 4easured .a,ple d A+sor,l A+sor- +a(ce at +a(ce 610(, of at sa,ple of %ef* .td* : of Chlorhe-! d!(e Kluco(ate
7t* of %ef* .ta(dard g,* 7t* of .a,ple ,l 4easured A+sor+a(ce at of %ef* .td* 4easur ed A+sor+a(ce at 610(, of sa,ple : of Chlorhe-!d !(e Kluco(ate
01 0# 05
0*6''" 0*6'"' 0*/01#
/0,l /0,l /0,l
/66 /66 /65
/6/ /6# /6/
100*6' ''*06 ''*6'
0*/0'0 0*6''# 0*6'"6
/0,l /0,l /0,l
/6" /6# /6#
/6$ /6/ /6/
''*'' 100*5' 100*#5
1a+el Cla!,
0*#: Chlorhe-!d!(e
0*#: Chlorhe-!d!(e Kluco(ate 100*0#: 10:
Kluco(ate 4ea( ''*$6: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : ''*'" : .ta(dard Dev!at!o( : G10 :

Prepared By Date of Issue/ ffect!ve Date : #6/01/#00"
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QC/VLD/10
01-16
B$*NS,P S,$.P
Checked By/ Approved By %ev!e& Date : #5/01/#010 %ev!s!o( )o* : 00
P.$P*S) # The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of .al+uta,ol .ulphate0 Bro,he-!(e 9cl 2 Kua!phe(s!( !( Bro(syp .yrup &!ll g!ve results &!th
accepta+le Accuracy0 1!(ear!ty0 %epeata+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the Bro(syp .yrup* SC*P) # Th!s ,ethod !s appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of .al+uta,ol .ulphate0 Bro,he-!(e 9cl 2 Kua!phe(s!(*

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0#-16
B$*NS,P S,$.P
M)(-*D # <Sal7"ta ol S"l0hate=
1* #* 5*
7e!gh accurately 100,g* of .al+uta,ol .ulphate as %efere(ce sta(dard a(d d!ssolve !( 100 ,l of &ater a(d prepare the d!lut!o( 100,cg/,l* !( &ater* Accurately &e!gh 8ua(t!ty of sa,ple !s e-tracted &!th &ater to get 100,cg*/,l !( respect of .al+uta,ol .ulphate* P!pette 5,l0 6,l0 /,l0 6,l 2 $,l of sta(dard a(d sa,ple solut!o( a(d add 5,l of .od!u, Car+o(ate solut!o(0 0*#,l of P-a,!(ophe(ol reage(t a(d volu,e !s adEusted to 10,l &!th &ater* 4easure the a+sor+a(ce &!thout delay at ,a-!,u, at a+out 65/(,0 aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of .al+uta,ol .ulphate peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g .al+uta,ol .ulphate solut!o( ser!al (o* o( =a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
6* /*
6* $* "*

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05-16
B$*NS,P S,$.P
L%N)A$%(, S(.D,
The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of .al+uta,ol .ulphate !( Bro(syp .yrup shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard .al+uta,ol .ulphate !( solut!o( of 50 ? $0,cg/,l co(ce(trat!o( 2 ra(ge 65/(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. Concentration o! Sal7"ta ol S"l0hate in 1* #* 5* 6* /* 50,cg;,l 60,cg;,l /0,cg;,l 60,cg;,l $0,cg;,l c23 l Peak area o! 6'/ $5' $'/ "#' """

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06-16
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$)P)A(%B%L%(, S(.D, %epeat!+!l!ty of assay ,ethod of .al+uta,ol .ulphate !( Bro(syp .yrup shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard .al+uta,ol .ulphate !( solut!o( of 50 ,cg/,l co(ce(trat!o( 2 ra(ge 65/(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, S.No. 1 #* 5* 6* /* Concentration in 50,cg;,l 50,cg;,l 50,cg;,l 50,cg;,l 50,cg;,l c23 l Peak area 6'" $00 6'$ 6'/ $05

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0/-16
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Test co(ce(trat!o( of .al+uta,ol .ulphate used @ 50,cg;,l* )u,+er of test solut!o( used @ / 6'"A$00A6'$A6'/A$05 Average area @ ----------------------------------/ @ 6'"*6
Dev* . @
B6'"-6'"*6C# AB$00-6'"*6C# AB6'$-6'"*6C# AB6'/-6'"*6C# AB$05-6'"*6C# [ ---------------------------------------------------------------------------------------] 1/# /-1 0*56A 1*'6A #*/6A 1#*'6 A 1'*56 @ [-------------------------------------------]1/# 6 5$*# @ [ ----- ----]1/# 6 @ [ '*5 ] @ 5*06'
1/#
$SD
5*06' - 100 @ -----------------6'"*6
@ 0*656 :
1!,!t

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06-16
B$*NS,P S,$.P
$.44)DN)SS S(.D,
The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of .al+uta,ol .ulphate !( Bro(syp .yrup shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B%aE(!sh Fohl!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of 4easure .a,ple d ,l A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 65/(, of sa,ple : of .al+uta, ol
7t* of %ef* .ta(dard g,* 7t* of .a,ple ,l 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 65/(, of sa,ple : of .al+uta, ol
01 0# 05
0*1#0' 0*1#16 0*1#06
/,l /,l /,l
6'" 6'6 6'/
$0# 6'$ 6'"
100*5# 100*$6 ''*$$
0*1#1" 0*1#06 0*1#1"
/,l /,l /,l
6'/ 6'6 6'"
6'6 6'6 $01
100*5/ ''*## 100*'5
1a+el Cla!, #,g* / /,l 4ea( 100*#": .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : 100*16: .ta(dard Dev!at!o( : G10 :
# ,g* / /,l 100*'5: 10:

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0$-16
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M)(-*D # <Bro he1ine -cl= 1* 7e!gh accurately 60,g* of Bro,he-!(e 9cl* a(d tra(sfer to a separat!(g fu((el0 +as!fy &!th /,l of d!lute A,,o(!a solut!o( 0 add #/,l* of &ater a(d e-tract &!th for #/,l
port!o(s of Chlorofor, layer through a(hydrous .od!u, .ulphate prev!ously &ashed &!th Chlorofor,* vaporate Chlorofor, layer a(d d!ssolve res!due !( 0*14 4etha(ol!c 9ydrochlor!c Ac!d to produce 100,l* B600,cg*/ ,l*C* <urther ,ake the d!lut!o( &!th 4etha(ol!c 9ydrochlor!c Ac!d to get f!(al co(ce(trat!o( of 60,cg/,l* #* 5* 4easure accurately sa,ple e8u!vale(t to 6,g* of Bro,he-!(e 9cl*0 add #/,l* &ater a(d co(t!(ue &!th the procedure as descr!+ed u(der preparat!o( of sta(dard solut!o(* P!pette #,l0 5,l0 6,l0 /,l 2 6,l of sta(dard a(d sa,ple solut!o(0 add ",l of P-d!,ethyl-a,!(o+e(Daldehyde B10:&/v !( 4etha(olC 2 /,l* of 9ydrochlor!c Ac!d ,!- a(d allo& the sta(d for 10 ,!(utes a(d the( ,ake up the volu,e to #/,l* &!th &ater* 4easure the a+sor+a(ce at ,a-!,u, at a+out 6#/(,0 aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of Bro,he-!(e 9cl peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g Bro,he-!(e 9cl* solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
6* /*
6* $* "*

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0"-16
B$*NS,P S,$.P
1!(ear!ty of assay ,ethod of Bro,he-!(e 9cl !( Bro(syp .yrup shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Bro,he-!(e 9cl !( solut!o( of 5*# ? '*6,cg/,l co(ce(trat!o( 2 ra(ge 6#/(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. Concentration o! Bro he1ine -cl. in 1* #* 5* 6* /* 5*#,cg;,l 6*",cg;,l 6*6,cg;,l "*0,cg;,l '*6,cg;,l c23 l Peak area o! /6/ /'" 66# 6'1 $5#

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0'-16
B$*NS,P S,$.P
$)P)A(%B%L%(, S(.D,
%epeat!+!l!ty of assay ,ethod of Bro,he-!(e 9cl !( Bro(syp .yrup shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Bro,he-!(e 9cl !( solut!o( of 5*#,cg/,l co(ce(trat!o( 2 ra(ge 6#/(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, Sr. No. 1 #* 5* 6* /* Concentration in 5*#,cg;,l 5*#,cg;,l 5*#,cg;,l 5*#,cg;,l 5*#,cg;,l c23 l Peak area /6/ /6$ /6" /6/ /6#

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10-16
B$*NS,P S,$.P
Test co(ce(trat!o( of Bro,he-!(e 9cl* used @ 5*#,cg;,l* )u,+er of test solut!o( used @ /
/6/A/6$A/6"A/6/A/6# Average area @ ----------------------------------/ Dev* . @
@ /6/*6
B/6/-/6/*6C# AB/6$-/6/*6 C# AB/6"-/6/*6C# AB/6/-/6/*6C# AB/6#-/6/*6C# [ ---------------------------------------------------------------------------------------] 1/# /-1 0*16A#*/6A6*$6A0*16A11*/6 @ [--------------------------------------------]1/# 6 #1*# @ [ ----- ----]1/# 6 @ [ /*5 ] @ #*50#
1/#
$SD
#*50# - 100 @ -----------------/6/*6
@ 0*6## :
1!,!t

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11-16
B$*NS,P S,$.P
$.44)DN)SS S(.D,
The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of Bro,he-!(e 9cl !( Bro(syp .yrup shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of 4easure .a,ple d ,l A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 6#/(, of sa,ple : of Bro,he!(e
7t* of %ef* .ta(dard g,* 7t* of .a,ple ,l 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 6#/(, of sa,ple : of Bro,he-! (e
01 0# 05
0*05'" 0*05'6 0*05''
/,l /,l /,l
/6" /66 /65
/66 /6" /6/
''*15 ''*$# 100*11
0*05'6 0*05'' 0*0601
/,l /,l /,l
/6/ /61 /6#
/6# /65 /65
'"*6/ 100*11 100*65
1a+el Cla!, 6,g* Bro,he-!(e//,l 4ea( ''*6/: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : ''*66 .ta(dard Dev!at!o( : G10:
6,g* Bro,he-!(e//,l ''*66: 10:

Prepared By Date of Issue/ ffect!ve Date : #6/01/#00" M)(-*D # <4"ai0henesin= 1*
Total Page:
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1#-16
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7e!gh accurately 100,g* of Kua!phe(es!(0 tra(sfer to a separat!(g fu((el* Add #0,l of &ater a(d /,l* of .od!u, hydro-!de solut!o( B#0:&/vC* -tract &!th for 60,l port!o(s of petroleu, ether B60-"0oCC * D!scard ether layer0 collect the a8ueous layer a(d e-tract
for #0,l port!o(s of chlorofor,* Pass co,+!(ed chlorofor, layer throught a(hydrous sod!u, .ulphate a(d ,ake up to 100,l &!th chlorofor,* #* 5* 6* /* 4easure accurately sa,ple e8u!vale(t to 100,g* of su+sta(ce0 add #0,l of &ater a(d co(t!(ue the procedure as descr!+ed u(der preparat!o( of sta(dard solut!o(* P!pette /,l0 6,l0 $,l0 ",l 2 10,l of sta(dard a(d sa,ple solut!o(0 a(d ,ake up the volu,e 100,l* &!th ,etha(ol* 4easure the a+sor+a(ce at ,a-!,u, at a+out #$/(,0 aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of Kua!phe(es!( peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g Kua!phe(es!( solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
6* $* "*

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B$*NS,P S,$.P
L%N)A$%(, S(.D,
The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of Kua!phe(es!( !( Bro(syp .yrup shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Kua!phe(es!( !( solut!o( of /0 ? 100,cg/,l co(ce(trat!o( 2 ra(ge #$/(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, Sr.No. Concentration o! 4"ai0henesin in 1* #* 5* 6* /* /0,cg;,l 60,cg;,l $0,cg;,l "0,cg;,l 100,cg;,l c23 l Peak area o! 61' 660 /0# /6# 60/

Total Page:
QC/VLD/10
16-16
B$*NS,P S,$.P
$)P)A(%B%L%(, S(.D,
%epeat!+!l!ty of assay ,ethod of Kua!phe(es!( !( Bro(syp .yrup shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Kua!phe(es!( !( solut!o( of /0 ,cg/,l co(ce(trat!o( 2 ra(ge #$/(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(,
Sr.No. 1 #* 5* 6* /*
Concentration in /0,cg;,l /0,cg;,l /0,cg;,l /0,cg;,l /0,cg;,l
c23 l
Peak area 6#1 61' 6#6 6## 6#0

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QC/VLD/10
1/-16
B$*NS,P S,$.P
Test co(ce(trat!o( of Kua!phe(s!( used @ /0,cg;,l* )u,+er of test solut!o( used @ /
6#1A61'A6#6A6##A6#0 Average area @ ----------------------------------/
@ 6#1*#
Dev* . @
B6#1-6#1*#C# AB61'-6#1*#C# AB6#6-6#1*#C# AB6##-6#1*#C# AB6#0-6#1*#C# [ ---------------------------------------------------------------------------------------] 1/# /-1 0*06A6*"6A $*"6 A 0*66 A 1*66 @ [--------------------------------------------]1/# 6 16*" @ [ ----- ----]1/# 6 @ [ 5*$ ] @ 1*'#6
1/#
$SD
1*'#6 - 100 @ -----------------6#1*# :
@ 0*6/$ :
1!,!t

Total Page:
QC/VLD/10
16-16
B$*NS,P S,$.P
$.44)DN)SS S(.D,
The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of Kua!phe(s!( !( Bro(syp .yrup shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C A(alyst- II B%aE(!sh Fohl!C Date of a(alys!s : Date of a(alys!s : I(stru,e(t 2 4odel : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics .V S0ectro0hoto eter5 Systronics 116 116 1ocat!o( : %nstr" ent La7. 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of 4easure .a,ple d ,l A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at #$/(, of sa,ple : of Kua!ph e(es!( 7t* of %ef* .ta(dard g,* 7t* of .a,ple ,l 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at #$/(, of sa,ple : of Kua!phe( es!(
01 0# 05
1a+el Cla!, /0,g Kua!phe(es!(//,l 1a+el Cla!, 4ea( 4ea( .ta(dard Dev!at!o( 10: .ta(dard Dev!at!o( Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : .ta(dard Dev!at!o( : G10 :
/0,g Kua!phe(es!(//,l 10:

Prepared By Date of Issue/ ffect!ve Date : 0"/0#/#00"
Total Page:
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01-16
B)CL*SA$&NC C$)AM
Checked By/ Approved By %ev!e& Date : 0$/0#/#010 %ev!s!o( )o* : 00
P.$P*S) # The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of Beclo,ethaso(e D!prop!o(ate0 )eo,yc!( .ulphate 2 Clotr!,aDole !( Beclosar-)C Crea, &!ll g!ve results
&!th accepta+le Accuracy0 1!(ear!ty0 %epeat!+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the Beclosar-)C Crea,* SC*P) # Th!s ,ethod !s appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of Beclo,ethaso(e D!prop!o(ate0 )eo,yc!( .ulphate 2 Clotr!,aDole*
$)SP*NS%B%L%(,# 1* 3ual!ty Co(trol 4a(ager* #* Asstt* 3ual!ty Co(trol Che,!st* VAL%DA(%*N PA$AM)()$S# 1* 1!(ear!ty* #* %epeat!+!l!ty* 5* %elat!ve .ta(dard Dev!at!o(* 6* %ugged(ess*

Prepared By Date of Issue/ ffect!ve Date : 0"/0#/#00" M)(-*D # BBeclo,ethaso(e D!prop!o(ateC
Total Page:
QC/VLD/11
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B)CL*SA$&NC C$)AM
1*
7e!gh accurately /0,g* of Beclo,ethaso(e D!prop!o(ate a(d d!ssolve !( 100,l* of ,etha(ol* <urther d!lute 1,l* a(d ,ake up the volu,e to /0,l* &!th ,etha(ol* Th!s ,akes 10,cg*/,l d!lut!o( of Beclo,ethaso(e D!prop!o(ate* 7e!ght accurately sa,ple Bcrea,C e8u!vale(t to 0*/,g of Beclo,ethaso(e D!prop!o(ate a(d d!ssolve !( #/,l* of ,etha(ol* <!lter a(d the( ,ake up the volu,e to /0,l* &!th ,etha(ol* P!pette 1,l0 #,l0 5,l0 6,l 2 /,l of sta(dard a(d sa,ple solut!o(0 add 6,l* of 0*14 tetra+utyl a,,o(!u, hydro-!de BTBA9C reage(t a(d #,l* of 0*/:&/v of TetraDol!u, +lue BBTLC solut!o(* 9eat the solut!o( o( &ater +ath for 1/,!(utes0 cool the solut!o( a(d add 10,l* Klac!al Acet!c ac!d* 4easure the a+sor+a(ce &!thout delay at ,a-!,u, at a+out /1/(,0 aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of Beclo,ethaso(e D!prop!o(ate peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g Beclo,ethaso(e D!prop!o(ate solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
#*
5*
6* /*
6* $* "*

Total Page:
QC/VLD/11
05-16
B)CL*SA$&NC C$)AM
L%N)A$%(, S(.D,
The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of Beclo,ethaso(e D!prop!o(ate !( Beclosar-)C Crea, shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Beclo,ethaso(e D!prop!o(ate !( solut!o( of 1 ? /,cg/,l co(ce(trat!o( 2 ra(ge /1/(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, .r*)o* Co(ce(trat!o( of Beclo,ethaso(e D!prop!o(ate !( ,cg;,l 1* #* 5* 6* /* 1,cg;,l #,cg;,l 5,cg;,l 6,cg;,l /,cg;,l Peak area of 6"0 $6# $'1 "5' "$#

Total Page:
QC/VLD/11
06-16
B)CL*SA$&NC C$)AM
$)P)A(%B%L%(, S(.D, %epeat!+!l!ty of assay ,ethod of Beclo,ethaso(e D!prop!o(ate !( Beclosar-)C Crea, shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Beclo,ethaso(e D!prop!o(ate !( solut!o( of 1 ,cg/,l co(ce(trat!o( 2 ra(ge /1/(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, .r*)o* 1 #* 5* 6* /* Co(ce(trat!o( !( ,cg;,l 1,cg;,l 1,cg;,l 1,cg;,l 1,cg;,l 1,cg;,l Peak area 6"0 6"# 6"1 6"0 6"/

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QC/VLD/11
0/-16
B)CL*SA$&NC C$)AM
Test co(ce(trat!o( of Beclo,ethaso(e D!prop!o(ate used @ 1,cg;,l* )u,+er of test solut!o( used @ / 6"0A6"#A6"1A6"0A6"/ Average area @ ----------------------------------/ @ 6"1*6
Dev* . @
B6"0-6"1*6C# AB6"#-6"1*6C# AB6"1-6"1*6C# AB6"0-6"1*6C# AB6"/-6"1*6C# [ ---------------------------------------------------------------------------------------] 1/# /-1 #*/6A0*16A0*56A#*/6A11*/6 @ [---------------------------------------]1/# 6 1$*# @ [ ----- ----]1/# 6 @ [ 6*5 ] 1/# @ #*0$56
$SD
#*0$56 - 100 @ -----------------6"1*6
@ 0*506# :
1!,!t

Total Page:
QC/VLD/11
06-16
B)CL*SA$&NC C$)AM
$.44)DN)SS S(.D,
The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of Beclo,ethaso(e D!prop!o(ate !( Beclosar-)C Crea, shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of 4easure .a,ple d g, A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at /1/(, of sa,ple : of Beclo,e thaso(e
7t* of %ef* .ta(dard g,* 7t* of .a,ple ,l 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at /1/(, of sa,ple : of Beclo,et haso(e
01 0# 05
0*06'" 0*06'# 0*0/0#
1*''6' #*0015 1*''$/
6"5 6"/ 6"6
6"1 6"6 6"6
''*/# '"*/5 100*""
0*0/06 0*06'6 0*06'$
1*''$" 1*''"# #*001"
6"# 6"# 6"6
6"6 6"6 6"6
100*6# ''*1' ''*61
1a+el Cla!, 0*0#/: &/& 4ea( ''*66: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : ''*"' : .ta(dard Dev!at!o( : G10:
0*0#/: &/& 100*16: 10:

Prepared By Date of Issue/ ffect!ve Date : 0"/0#/#00" M)(-*D # B)eo,yc!( .ulphateC 1*
Total Page:
QC/VLD/11
0$-16
B)CL*SA$&NC C$)AM
7e!gh accurately 100,g* of )eo,yc!( .ulphate a(d d!ssolve !( 100,l* of phosphate +uffer p9 "*0 a(d prepare the d!lut!o( 100,cg/,l* !( phosphate +uffer*
#*
7e!ght accurately sa,ple Bcrea,C e8u!vale(t to 10,g of )eo,yc!( .ulphate0 suspe(d !( #/,l* of phosphate +uffer a(d e-tract &!th Chlorofor, B5 - 50,lC* Collect chlorofor, !( a dry 100,l volu,etr!c flask f!lter!(g each layer through sa,e a(hydrous sod!u, .ulphate +ed* %!(se sod!u, .ulphate layer &!th chlorofor,0 the co,+!(ed chlorofor, layer !s ,ade up of volu,e* A8ueous +uffered layer heated !( &ater +ath t!ll (o percept!+le s,ell of chlorofor, !s d!luted to 100,l &!th phosphate +uffer a(d used for est!,at!o( of )eo,yc!( .ulphate* P!pette /,l0 6,l0 $,l0 ",l 2 ',l of sta(dard a(d sa,ple solut!o(0 add /,l* of freshly prepared (!(hydr!( reage(t a(d heat !( &ater +ath for #0 ,!(utes0 cool0 add # ,l* of ,etha(ol a(d d!lute to /0,l &!th phosphate +uffer* 4easure the a+sor+a(ce &!thout delay at ,a-!,u, at a+out /$0(,0 aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of )eo,yc!( .ulphate peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g )eo,yc!( .ulphate solut!o( ser!al (o* o( =a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
5*
6* /*
6* $* "*

Total Page:
QC/VLD/11
0"-16
B)CL*SA$&NC C$)AM
1!(ear!ty of assay ,ethod of )eo,yc!( .ulphate !( Beclosar-)C Crea, shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard )eo,yc!( .ulphate !( solut!o( of 10 ? 1",cg/,l co(ce(trat!o( 2 ra(ge /$0(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, .r*)o* Co(ce(trat!o( of )eo,yc!( .ulphate !( ,cg;,l 1* #* 5* 6* /* 10,cg;,l 1#,cg;,l 16,cg;,l 16,cg;,l 1",cg;,l Peak area of 6/# 6'" $6' "0/ "6#

Total Page:
QC/VLD/11
0'-16
B)CL*SA$&NC C$)AM
$)P)A(%B%L%(, S(.D,
%epeat!+!l!ty of assay ,ethod of )eo,yc!( .ulphate !( Beclosar-)C Crea, shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard )eo,yc!( .ulphate !( solut!o( of 10,cg/,l co(ce(trat!o( 2 ra(ge /$0(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, .r*)o* 1 #* 5* 6* /* Co(ce(trat!o( !( ,cg;,l 10,cg;,l 10,cg;,l 10,cg;,l 10,cg;,l 10,cg;,l Peak area 6/0 6/# 6/6 66" 6/$

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QC/VLD/11
10-16
B)CL*SA$&NC C$)AM
Test co(ce(trat!o( of )eo,yc!( .ulphate used @ 10,cg;,l* )u,+er of test solut!o( used @ / 6/0A6/#A6/6A66"A6/$ Average area @ ----------------------------------/ @ 6/#*#
Dev* . @
B6/0-6/#*#C# AB6/#-6/#*#C# AB6/6-6/#*#C# AB66"-6/#*#C# AB6/$-6/#*#C# [ ---------------------------------------------------------------------------------------] 1/# /-1 6*"6A0*06A5*#6A1$*66A#5*06 @ [---------------------------------------]1/# 6 6"*" @ [ ----- ----]1/# 6 @ [ 1#*# ] 1/# @ 5*6'5
$SD
5*6'5 - 100 @ -----------------6/#*#
@ 0*/56 :
1!,!t

Total Page:
QC/VLD/11
11-16
B)CL*SA$&NC C$)AM
$.44)DN)SS S(.D,
The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of )eo,yc!( .ulphate !( Beclosar-)C Crea, shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g,* 7t* of 4easure .a,ple d g,* A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at /$0(, of sa,ple : of )eo,yc! (
7t* of %ef* .ta(dard g,* 7t* of .a,ple g,* 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at /$0(, of sa,ple : of )eo,yc! (
01 0# 05
0*0''" 0*0''/ 0*100"
#*0#/6 #*0106 1*'''6
6/6 6/0 6/1
6/# 6/# 66'
'"*05 ''*5$ 100*6#
0*0''/ 0*0''" 0*10#'
#*0160 #*00/' 1*''"'
6/# 6/5 6/6
66' 6/6 6/"
'"*5$ ''*$1 105*55
1a+el Cla!, 0*/: &/& 4ea( ''*56: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : ''*"': .ta(dard Dev!at!o( : G10
0*/: &/& 100*6/ : 10:

Total Page:
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1#-16
B)CL*SA$&NC C$)AM
M)(-*D #
BClotr!,aDoleC 1* #* 5* 7e!gh accurately refere(ce sta(dard 100,g* of Clotr!,aDole a(d d!ssolve !( 100,l* of 0*14 hydrochlor!c ac!d a(d prepare the d!lut!o( 100,cg*/,l of Clotr!,aDole* 7e!gh accurately sa,ple e8u!vale(t to 100,g* of Clotr!,aDole a(d d!ssolve !( 100,l* of 0*14 hydrochlor!c ac!d a(d prepare the d!lut!o( 100,cg*/,l of Clotr!,aDole* P!pette 1,l0 #,l0 5,l0 6,l 2 /,l of sta(dard a(d sa,ple d!lut!o(0 add 5,l* of c!tr!c ac!d solut!o( a(d #,l of dye solut!o(* -tract the colour &!th three " ,l port!o(s of chlorofor,* 4ake up the volu,e to #/,l a(d pass through a(hydrous sod!u, .ulphate* 4easure the a+sor+a(ce &!thout delay at ,a-!,u, at a+out 6##(,0 aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of Clotr!,aDole peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g Clotr!,aDole solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
6* /*
6* $* "*

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QC/VLD/11
15-16
B)CL*SA$&NC C$)AM
L%N)A$%(, S(.D,
The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of Clotr!,aDole !( Beclosar-)C Crea, shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Clotr!,aDole !( solut!o( of 6 ? #0,cg/,l co(ce(trat!o( 2 ra(ge 6##(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ L%N)A$%(, .r*)o* Co(ce(trat!o( of Clotr!,aDole !( ,cg;,l 1* #* 5* 6* /* 6,cg;,l ",cg;,l 1#,cg;,l 16,cg;,l #0,cg;,l Peak area of /'/ 65# 6"# $5/ $'/

Total Page:
QC/VLD/11
16-16
B)CL*SA$&NC C$)AM
$)P)A(%B%L%(, S(.D, %epeat!+!l!ty of assay ,ethod of Clotr!,aDole !( Beclosar-)C Crea, shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard Clotr!,aDole !( solut!o( of 6,cg/,l co(ce(trat!o( 2 ra(ge 6##(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, .r*)o* 1 #* 5* 6* /* Co(ce(trat!o( !( ,cg;,l 6,cg;,l 6,cg;,l 6,cg;,l 6,cg;,l 6,cg;,l Peak area /'/ /'# /'5 /'/ /'6

Total Page:
QC/VLD/11
1/-16
B)CL*SA$&NC C$)AM
Test co(ce(trat!o( of )eo,yc!( .ulphate used @ 6,cg;,l* )u,+er of test solut!o( used @ / /'/A/'#A/'5A/'/A/'6 Average area @ ----------------------------------/ @ /'6*#
Dev* . @
B/'/-/'6*#C# AB/'#-/'6*#C# AB/'5-/'6*#C# AB/'/-/'6*#C# AB/'6-/'6*#C# [ ---------------------------------------------------------------------------------------] 1/# /-1 0*66 A 6*"6 A 1*66 A 0*66 A 5*#6 @ [------------------------------------------]1/# 6 10*" @ [ ----- ----]1/# 6 @ [ #*$ ] 1/# @ 1*6651
$SD
1*6651 - 100 @ -----------------/'6*#
@ 0*#$6 :
1!,!t

Total Page:
QC/VLD/11
16-16
B)CL*SA$&NC C$)AM
$.44)DN)SS S(.D, The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of Clotr!,aDole !( Beclosar-)C Crea, shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B%aE(!sh Fohl!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of 7t* of 4easured %ef* .a,ple g, A+sor.ta(dard +a(ce at g, of %ef* .td* 4easur ed A+sor+a(ce at 6##(, of sa,ple : of Clotr!,a Dole
7t* of %ef* .ta(dard g, 7t* of .a,ple g, 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 6##(, of sa,ple : of Clotr!,aD ole
01 0# 05
0*0''$ 0*100/ 0*''"'
10*00/6 '*''6' 10*01#/
/'6 /'# /'5
/'" /'5 /'0
100*05 100*$6 ''*5#
0*100# 0*0''" 0*101#
'*''6' '*''"# 10*001/
/'5 /'" /'$
/'/ /'/ /''
100*/$ ''*5# 101*/5
1a+el Cla!, 1: &/& 4ea( 100*05: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : 100*#/: .ta(dard Dev!at!o( : G10:
1: &/& 100*6$: 10:

Assay Method Validation
Total Page:
QC/VLD/18
01-11
Na e o! the Prod"ct#
Prepared By
M*VSA$ 4)L
Checked By/ Approved By %ev!e& Date : 05/11/#00' %ev!s!o( )o* : 00
Date of Issue/ ffect!ve Date : 06/11/#00$
P.$P*S) # The esta+l!sh docu,e(ted ev!de(ce &h!ch &!ll prov!de a h!gh degree of assura(ce that the a(alyt!cal ,ethod for assay of D!clofe(ac D!ethyla,!(e 2 4ethylsal!cylate !( 4ovsar Kel &!ll g!ve results &!th accepta+le Accuracy0 1!(ear!ty0 %epeat!+!l!ty0 %elat!ve .ta(dard Dev!at!o( 2 %ugged(ess &he( appl!ed to the 4ovsar Kel* SC*P) # Th!s ,ethod !s appl!es to the procedure &h!ch !s used for calculat!o( a(d assay of D!clofe(ac d!ethyla,!(e 2 4ethylsal!cylate*
$)SP*NS%B%L%(,# 1* 3ual!ty Co(trol 4a(ager* #* Asstt* 3ual!ty Co(trol Che,!st*
VAL%DA(%*N PA$AM)()$S# 1* 1!(ear!ty* #* %epeat!+!l!ty* 5* %elat!ve .ta(dard Dev!at!o(* 6* %ugged(ess*

Total Page:
QC/VLD/18
0#-11
Prepared By
M*VSA$ 4)L
M)(-*D # BD!clofe(ac d!ethyla,!(e C 1* 7e!gh accurately /0,g* of D!clofe(ac sod!u, &ork!(g sta(dard !( a 100,l volu,etr!c flask* D!ssolve &!th phosphate +uffer a(d ,ake up to 100,l &!th sa,e solut!o( a(d prepared the d!lut!o( /0,cg*/,l* of D!clofe(ac sod!u,* 7e!ght accurately sa,ple e8u!vale(t to /,g of D!clofe(ac sod!u, !( a 100,l volu,etr!c flask a(d d!ssolve !( 100,l phosphate +uffer* P!pette 10,l0 1#,l0 1/,l0 1",l 2 #0,l of sta(dard a(d sa,ple solut!o( separately to each fu((el add /,l of ,ethyle(e +lue solut!o( a(d e-tract &!th B10A10A/,lC of chlorofor, pass!(g each e-tract through a(hydrous sod!u, .ulphate0 d!lute to #/,l &!th chlorofor, ,!- to ,ake ho,oge(eous* 4easure the a+sor+a(ce &!thout delay at ,a-!,u, at a+out 6/0(,0 aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of D!clofe(ac d!ethyla,!(e peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >-a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g D!clofe(ac d!ethyla,!(e solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
#* 5*
6* /*
6* $* "*

Total Page:
QC/VLD/18
05-11
Prepared By
M*VSA$ 4)L
L%N)A$%(, S(.D, The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of D!clofe(ac d!ethyla,!(e !( 4ovsar Kel shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard D!clofe(ac d!ethyla,!(e !( solut!o( of #0 ? 60,cg/,l co(ce(trat!o( 2 ra(ge 6/0(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ L%N)A$%(, .r*)o* Co(ce(trat!o( of D!clofe(ac d!ethyla,!(e !( ,cg;,l 1* #* 5* 6* /* #0,cg;,l #6,cg;,l 50,cg;,l 56,cg;,l 60,cg;,l Peak area of $16 $6# $'/ "6# "$"
Total Page:
06-11

Prepared By
QC/VLD/18
M*VSA$ 4)L
$)P)A(%B%L%(, S(.D, %epeat!+!l!ty of assay ,ethod of D!clofe(ac d!ethyla,!(e !( 4ovsar Kel shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard D!clofe(ac d!ethyla,!(e !( solut!o( of #0 ,cg/,l co(ce(trat!o( 2 ra(ge 6/0(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(* *BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(, .r*)o* 1 #* 5* 6* /* Co(ce(trat!o( !( ,cg;,l #0,cg;,l #0,cg;,l #0,cg;,l #0,cg;,l #0,cg;,l Peak area $1' $16 $1" $## $#0

Total Page:
QC/VLD/18
0/-11
M*VSA$ 4)L
Test co(ce(trat!o( of D!clofe(ac d!ethyla,!(e used @ #0,cg;,l* )u,+er of test solut!o( used @ / $1'A$16A$1"A$##A$#0 Average area @ ----------------------------------/ @ $1"*6
Dev* . @
B$1'-$1"*6C# AB$16-$1"*6C# AB$1"-$1"*6C# AB$##-$1"*6C# AB$#0-$1"*6C# [ ---------------------------------------------------------------------------------------] 1/# /-1 0*16A#1*16A 0*56A 11*/6A 1*'6 @ [------------------------------------------]1/# 6 5/*# @ [ ----- ----]1/# 6 @ [ "*" ] 1/# @ #*'666
$SD
#*'666 - 100 @ -----------------$1"*6 :
@ 0*61# :
1!,!t

Total Page:
QC/VLD/18
06-11
M*VSA$ 4)L
$.44)DN)SS S(.D, The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of D!clofe(ac d!ethyla,!(e !( 4ovsar Kel shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B%aE(!sh Fohl!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g, 7t* of 4easured 4easured .a,ple A+sor+a A+sor+a(c g,* (ce at e at of %ef* 6/0(, of .td* sa,ple : of
7t* of %ef* .ta(dard g,* 7t* of .a,ple g,* 4easured A+sor+a(ce at of %ef* .td* 4easured A+sor+a(ce at 6/0(, of sa,ple : of
D!clof e(ac d!ethyl a,!(e

''*$" ''*"0 ''*/#
D!clofe (ac d!ethyl a,!(e

100*05 ''*5' 100*66
01 0# 05
0*06'5 0*0/01 0*06''
0*/01# 0*/006 0*6''5
$1/ $1" $1'
$1" $16 $16
0*06'" 0*06'6 0*0/0#
0*6''# 0*6'"6 0*/01#
$1" $16 $1'
$#0 $1" $#1
1a+el Cla!, 1*16: &/& 4ea( ''*56: .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : ''*"" : .ta(dard Dev!at!o( : G10:
1*16: &/& 100*66 10:

Assay Method Validation Na e o! the Prod"ct# M*VSA$ 4)L
Total Page:
QC/VLD/18
0$-11
M)(-*D # B4ethylsal!cylateC 1* 7e!gh accurately 100,g* of 4ethylsal!cylate as &ork!(g sta(dard !( a 100,l volu,etr!c flask a(d d!ssolve !( 0*0#4 hydrochlor!c ac!d a(d ,ake up to produced 100,l0 aga!( d!lute 1/,l of the result!(g solut!o( to 100,l &!th 0*0#4 hydrochlor!c ac!d* 7e!ght accurately e8u!vale(t to 100,g of 4ethyl sal!cylate !( a /00,l co(!cal flask add 50,l of 0*/4 sod!u, hydro-!de a(d #0,l of ,ethyl alcohol0 ,!- a(d reflu- for o(e hour o( stea, +ath to spo(!fy a(d hydrolyse0 cool to roo, te,perature a(d add #0,l of 1*04 hydrochlor!c ac!d a(d d!lute to 100,l &!th &ater a(d f!lter* <urther d!lute 1/,l to 100,l &!th 0*0#4 hydrochlor!c ac!d* P!pette 10,l0 1/,l0 #0,l0 #/,l 2 50,l of sta(dard a(d sa,ple solut!o( !( separately fu((el a(d e-tract &!th #/,l of chlorofor,0 separate chlorofor, layer !( a dry test tu+e* To / ,l of chlorofor, layer add 10,l of ferr!c a,,o(!u, sulfate reage(t a(d separate the a8ueous layer* 4easure the a+sor+a(ce &!thout delay at ,a-!,u, at a+out /50(,0 aga!(st respect!ve +la(k a(d ta+ulate the o+served data !( the o+servat!o( ta+le* Plot l!(ear!ty curve fro, the d!ffere(t co(ce(trat!o( correspo(d!(g area of 4ethylsal!cylate peak* Tak!(g co(ce(trat!o( o( =-a-!s a(d correspo(d!(g peak o( >a-!s* Plot graph should +e co((ected at least three po!(ts* Plot repeata+!l!ty curve fro, +y tak!(g 4ethylsal!cylate solut!o( ser!al (o* o( =-a-!s a(d o+served peak area o( >-a-!s* Dra& a l!(e &h!ch should cover al,ost all the po!(ts* The resulted graph should +e al,ost parallel to the =-a-!s* * * Calculated the result +y co,par!so( &!th peak area o+ta!(ed !( sta(dard a(d sa,ple solut!o( respect!vely*
#*
5*
6* /*
6* $* "*

Total Page:
QC/VLD/18
0"-11
Prepared By
M*VSA$ 4)L
L%N)A$%(, S(.D, The l!(ear!ty of a( a(alyt!cal ,ethod !s !ts a+!l!ty to el!c!t test results data d!rectly proport!o(al to the co(ce(trat!o( of the a(alyte !( sa,ples &!th!( g!ve( ra(ge* 1!(ear!ty of assay ,ethod of 4ethylsal!cylate !( 4ovsar Kel shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard 4ethylsal!cylate !( solut!o( of 50 ? '0,cg/,l co(ce(trat!o( 2 ra(ge /50(,* 1!(ear!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ L%N)A$%(, .r*)o* Co(ce(trat!o( of 4ethylsal!cylate !( ,cg;,l 1* #* 5* 6* /* 50,cg;,l 6/,cg;,l 60,cg;,l $/,cg;,l '0,cg;,l Peak area 6"/ $/# $'6 "// """

Total Page:
QC/VLD/18
0'-11
M*VSA$ 4)L
$)P)A(%B%L%(, S(.D, %epeat!+!l!ty of assay ,ethod of 4ethylsal!cylate !( 4ovsar Kel shall +e stud!ed +y ,easur!(g the a+sor+a(ce of the sta(dard 4ethylsal!cylate !( solut!o( of 50,cg/,l co(ce(trat!o( 2 ra(ge /50(,* %epeat!+!l!ty curve shall +e plotted for a+sor+a(ce aga!(st co(ce(trat!o(*
*BS)$VA(%*N (ABL) /*$ $)P)A(%B%L%(,
.r*)o* 1 #* 5* 6* /*
Co(ce(trat!o( !( ,cg;,l 50,cg;,l 50,cg;,l 50,cg;,l 50,cg;,l 50,cg;,l
Peak area 6"$ 6"/ 6"6 6"6 6"/
Total Page:
10-11

Prepared By
QC/VLD/18
M*VSA$ 4)L
Test co(ce(trat!o( of 4ethylsal!cylate used @ 50,cg;,l* )u,+er of test solut!o( used @ / 6"$A6"/A6"6A6"6A6"/ Average area @ ----------------------------------/ @ 6"/*6
Dev* . @
B6"$-6"/*6C# AB6"/-6"/*6C# AB6"6-6"/*6C# AB6"6-6"/*6C# AB6"/-6"/*6C# [ ---------------------------------------------------------------------------------------] 1/# /-1 #*/6A0*16A1*'6A0*56A0*16 @ [----------------------------------------]1/# 6 @ /*# M ----- ----]1/# 6 [ 1*5 ] 1*1601 @ 0*166 :
1/#
@ @ $SD
1*1601 - 100 @ -----------------6"/*6
1!,!t
Total Page:
11-11

Prepared By
QC/VLD/18
M*VSA$ 4)L
$.44)DN)SS S(.D, The rugged(ess of a( a(alyt!cal ,ethod !s the degree of reproduc!+!l!ty of the test results o+ta!(ed +y the a(alys!s of the sa,ples fro, sa,e lot u(der a var!ety of (or,al test co(d!t!o(s B!*e* d!ffere(t la+orator!es0 a(alysts0 days 2 I(stru,e(tsC* The rugged(ess of assay ,ethod of 4ethylsal!cylate !( 4ovsar Kel shall +e stud!ed +y a(alyD!(g the sa,ples fro, sa,e lot +y t&o d!ffere(t a(alysts fro, sa,e la+oratory or at t&o d!ffere(t la+orator!es +y t&o d!ffere(t a(alysts o( t&o d!ffere(t days* $.44)DN)SS S(.D, DA(A %ugged(ess data for assay ,ethod +y t&o d!ffere(t a(alysts o( d!ffere(t days a(d d!ffere(t !(stru,e(t* .r* )o* A(alyst- I B.atpal .a!(!C Date of a(alys!s : I(stru,e(t 2 4odel : .V S0ectro0hoto eter5 Systronics 116 1ocat!o( : %nstr" ent La7.
7t* of %ef* .ta(dard g, 7t* of 4easure 4easured .a,ple d A+sor+a(ce g, A+sor+ at /50(, a(ce at of sa,ple of %ef* .td* : of 4ethylsa l!cylate
7t* of %ef* .ta(dard g, 7t* of .a,ple g,* 4easured A+sor+a(c e at of %ef* .td* 4easured A+sor+a( ce at /50(, of sa,ple : of 4ethylsal !cylate
01 0# 05
0*0''" 0*100' 0*0''"
0*'''6 0*''"' 1*001#
6"6 6"6 6"$
6"6 6"/ 6"/
100*1/ 100*"$ ''*5'
0*101" 0*0''" 0*100'
0*'''6 1*001/ 0*'''6
6"$ 6"6 6"6
6"6 6"6 6"#
101*6" ''*'5 100*66
1a+el Cla!, 10: &/& 4ea( 100*51 : .ta(dard Dev!at!o( 10: Co,+!(!(g ,ea( of I 2 II of +oth the a(alysts : 4ea( : 100*/5: .ta(dard Dev!at!o( : G10:
10: &/& 100*$/: 10:

QC Assay Validation

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Sarthak Biotech Pvt. Ltd.

Assay Method Validation Na e o! the Prod"ct# SA$C%P&'00 (ABL)(

Checked By/ Approved By %ev!s!o( )o* : 00

Date of Issue/ ffect!ve Date : 1"/11/#00$ %ev!e& Date : 1$/11/#00'

degree of !( .arc!p1!(ear!ty0 appl!ed to

Sarthak Biotech Pvt. Ltd.

Checked By/ Approved By %ev!s!o( )o* : 00

Date of Issue/ ffect!ve Date : 1"/11/#00$ %ev!e& Date : 1$/11/#00'

Sarthak Biotech Pvt. Ltd.

Checked By/ Approved By %ev!s!o( )o* : 00

Date of Issue/ ffect!ve Date : 1"/11/#00$ %ev!e& Date : 1$/11/#00'

Sarthak Biotech Pvt. Ltd.

Sarthak Biotech Pvt. Ltd.

Assay Method Validation Na e o! the Prod"ct# SA$C%P&'00 (ABL)(

Checked By/ Approved By %ev!s!o( )o* : 00

Date of Issue/ ffect!ve Date : 1"/11/#00$ %ev!e& Date : 1$/11/#00'

: B )ot ,ore tha( #*0: C

Sarthak Biotech Pvt. Ltd.

0*116" 0*11/6 0*11/"

0*156" 0*15/# 0*156#

60# 60$ 60/

60" 61# 61/

100*11 ''*61 101*5/

0*116# 0*116/ 0*1166

0*156' 0*15/6 0*15/#

606 60' 61#

601 616 60"

''*65 101*1/ ''*//

Average&t*of ta+let 4ea( .ta(dard Dev!at!o(

6$/*1 ,g 100*06: 10:

Sarthak Biotech Pvt. Ltd.

Sarthak Biotech Pvt. Ltd.

Sarthak Biotech Pvt. Ltd.

Sarthak Biotech Pvt. Ltd.

Sarthak Biotech Pvt. Ltd.

Assay Method Validation Na e o! the Prod"ct#

Date of Issue/ ffect!ve Date : 1"/11/#00$

B/1/-/15*6C# AB/1#-/15*6C# AB/1/-/15*6C# AB/0'-/15*6C# AB/1'-/15*6C# 1/# [ ---------------------------------------------------------------------------------------] /-1

#*/6A1*'6A1*'6A1'*56A51*56 @ [---------------------------------------]1/# 6 /$*# @ [ -------] 1/# 6 @ [ 16*5]

5*$"1 - 100 @ -----------------/15*6

: B )ot ,ore tha( #*0: C

Sarthak Biotech Pvt. Ltd.

Assay Method Validation Na e o! the Prod"ct#

Date of Issue/ ffect!ve Date : 1"/11/#00$

0*06'" 0*0/01 0*0/1#

0*10#1 0*101' 0*10#'

/0' /11 /1'

/1# /1/ /1#

100*6$ 101*$ 100*$

0*06'' 0*0/1# 0*06"'

0*1006 0*101" 0*101#

/1# /06 /0"

/0/ /10 /16

'"*'$ 10#*'/ '"*'0

Average&t*of ta+let 4ea( .ta(dard Dev!at!o(

606*6 ,g 100*#$: 10:

Sarthak Biotech Pvt. Ltd.

Prepared By Date of Issue/ ffect!ve Date : 1'/1#/#00$

Checked By/ Approved By %ev!e& Date : 1"/1#/#00' %ev!s!o( )o* : 00

Sarthak Biotech Pvt. Ltd.

0116" 011/6 0*11/"

0156" 015/# 0*156#

10011 ''61 101*5/

0116# 0116/ 0*1166

0156' 015/6 0*15/#

''65 1011/ ''*//

6$/1 ,g 10006: 10:

B/1/-/156C# AB/1#-/156C# AB/1/-/156C# AB/0'-/156C# AB/1'-/15*6C# 1/# [ ---------------------------------------------------------------------------------------] /-1

#/6A1'6A1'6A1'56A5156 @ [---------------------------------------]1/# 6 /$# @ [ -------] 1/# 6 @ [ 16*5]

5$"1 - 100 @ -----------------/156

006'" 00/01 0*0/1#

010#1 0101' 0*10#'

1006$ 101$ 100*$

006'' 00/1# 0*06"'

01006 0101" 0*101#

'"'$ 10#'/ '"*'0

6066 ,g 100#$: 10:

P$C)D.$) </or Paraceta ol= 1

B/#/-/#6#C# AB/#"-/#6#C# AB/#$-/#6#C# AB/#6-/#6#C# AB/#/-/#6-#C# 1/# [ ---------------------------------------------------------------------------------------] /-1

166A5#6 A066A006A166 @ [---------------------------------------]1/# 6 6" @ [ -------]1/# 6 @ [ 1*$]

1505 - 100 @ -----------------/#6#

00/'" 00601 0*0/'#

00$"6 00$'# 0*0$"6

100"5 '"#5 ''*1'

0060# 00/'# 0*061#

00$"# 00$$' 0*0$'1

101'' '"$/ 101*'

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P$C)D.$) </or Ni es"lide= 1

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