HEALER’S LAB.

(UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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STP No. EFFECTIVE DATE REVIEW DATE
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STANDARD TESTING PROCEDURE

FOR
PARACETAMOL I.P.

Reference Indian Pharmacopoeia 2018

Molecular Formula C8H9NO2

Molecular Weight 151.2

Storage Condition Store protected from light and moisture.

Retest Period After 2years

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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STP No. EFFECTIVE DATE REVIEW DATE
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SR.NO. TEST SPECIFICATION

01 Description White crystal or a white, crystalline powder.

02 Solubility Freely soluble in ethanol (95%) and acetone; sparingly soluble

in water; very slightly soluble in dichloromethane and in ether.
03 Identification A) The infrared absorption spectra of sample preparation should
exhibit maxima at the same wavelength as that of standard
preparation.
B) The absorbance is not more than 0.44.
C) A violet colour develops which does not turn red.
D) Gives the test for acetyl groups.

05 Related Complies as per specification.

substances
06 Heavy Metals NMT 10 ppm, Method B.

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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07 Sulphated Ash NMT 0.1 %

08 Loss on drying NMT 0.5 %, determined on 1.0 g by drying in an oven at 105°.

09 Assay Limit 99.0 % to 101.0% of C8H9NO2, calculated on the dried

basis.

Reference: I.P. 2018 Page No. 2853

1.0 DESCRIPTION: Take about 3gm of sample over the white paper and examine
visually in a white light source. Check the appearance of Colour, nature and any visual
foreign particles.

Odour (whenever applicable): Examine 25gm of sample immediately after opening the
package. If any odour is noticeable, transfer the sample rapidly to an open container and
reexamine after 15 minutes and record the observation.

Warning: Do not smell hazardous chemicals

2.0 SOLUBILITY:

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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Freely soluble in ethanol (95%) and acetone; sparingly soluble in water; very slightly
soluble in dichloromethane and in ether.

Sr. No. Descriptive Term Solvent in ml Weight of sample

01 Very soluble Less than 1 1.0 gm
02 Freely soluble From 1 to 10 1.0 gm
03 Soluble From 10 to 30 1.0 gm
04 Sparingly Soluble From 30 to 100 1.0 gm
05 Slightly Soluble From 10 to 100 0.1 gm
06 Very Slightly Soluble From 10 to 100 0.01 gm
07 Practically insoluble 100 and above 0.01 gm

Weight and transfer the sample quantity in an appropriate test tube and make it into
solution by using the specified solvent described in the product specification.

Check the sample solution visually for any physical impurities like fibers, black particles,
white particles and any other foreign particles in front of white panel followed by its
observation in front of black panel of visual board and record the observations. Always
check the solubility at 15 ºC to 30ºC.

3.0 IDENTIFICATION:-

A) By FTIR: Compare the spectrum with that obtained with Paracetamol RS.

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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Requirement:
1) Fourier Transform Infrared Spectrophotometer
2) Agate Mortar and Pastel, holder, Hydraulic Press and Potassium bromide.

Standard preparation: Take 1mg of Paracetamol standard in Agate mortar pestle; add
about 300mg of potassium bromide (suitable for IR analysis), Grind it into fine powder
with the help of pestle. Transfer about 200mg of this fine powder into die holder and fix the
die into hydraulic press. Apply the pressure to 10tons.
Release the pressure the hydraulic press, remove the die and take out the pellet. The pellet
should be transparent. Place the pellet into pellet holder and put it into the sample
compartment and record the spectra between 4000 and 650cmˉ1

Sample preparation: Take 1mg of Paracetamol sample in Agate mortar pestle; add about
300mg of potassium bromide (suitable for IR analysis), Grind it into fine powder with the
help of pestle. Transfer about 200mg of this fine powder into die holder and fix the die into
hydraulic press. Apply the pressure to 10tons.
Release the pressure the hydraulic press, remove the die and take out the pellet. The pellet
should be transparent. Place the pellet into pellet holder and put it into the sample
compartment and record the spectra between 4000 and 650cmˉ1

Procedure: Compare the infrared absorption spectra obtained with standard preparation
and sample preparation. The infrared absorption spectra of sample preparation should
exhibit maxima at the same wavelength as that of standard preparation.

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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(B). LIGHT ABSORBANCE: By U.V.spectrophtometer.

Procedure: Take 50 mg of sample in 100 ml of volumetric flask and dissolved in

methanol. To 1ml of this solution add 0.5ml of 0.1M hydrochloric acid and dilute to 100ml
with methanol. Protect the resulting solution from bright light and immediately measure the
absorbance at 249 nm. The absorbance is not more than 0.44.

(C). Boil 100mg in 1ml of hydrochloric acid for 3 minute, add 10ml of water and cool; No
precipitate is produced. Add 0.05 ml of 0.0167 M potassium dichromate; a violet colour
develops which does not turn red.

(D). Test for acetyl groups:

Requirement:
(a) A test tube (about 180mm × 18mm) with a stopper.
(b) A test tube (about 100mm × 10mm) with a stopper.
(c) Orthophosphoric acid.
(d) Lanthanum nitrate solution.
(e) Water bath.
(f) 0.01M iodine.
(g) 2M ammonia.

Procedure: In a test tube (about 180mm × 18mm) place 10 to 20mg of the prescribed
quantity of the substance under examination and add 0.15 ml of orthophosphoric acid.
Close the test tube with a stopper through which passes a small test tube (about 100mm ×

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

Page 7 of 14
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10mm) containing water to act as a condenser. On the outside of the smaller tube, hang a
drop of lanthanum nitrate solution.
Except for substances hydrolysable only with difficulty, place the apparatus in a water bath
for 5minute and remove the small tube. Mix a drop with 0.05ml of 0.01M iodine on a
porcelain tile or glass slide and then add one drop of 2M ammonia at the edge of the mixed
drop; after 1 or 2minute a blue colour is produced at the junction of the two drops and the
colour intensifies and persists for a short time.
For substances hydrolysable only with difficulty, heat the mixture slowly to boiling point
over an open flame instead of using a water bath.

4.0 RELATED SUBSTANCES:-

Requirement:
(1)Instrument: A suitable High Performance Liquid Chromatography consisting of a
pump and UV-VIS detector.
(2)Column: 250mmX4.6mm 5µ C18
(3)Flow Rate: 1.5 ml/ minute
(4)Detector: UV 254nm
(5)Injection Volume: 20 µl
Mobile Phase: A mixture of 37.5 volumes of a 1.79per cent w/v solution of disodium
hydrogen phosphate ,37.5 volumes of a 0.78 per cent w/v solution of sodium dihydrogen
phosphate and 25 volume of methanol containing 0.46 per cent v/v of
Tetrabutylammonium hydroxide solution (40 per cent w/v)

Test solution:- Dissolve 0.2 g of the substance under examination in 2.5 ml of methanol
containing 0.46 per cent w/v of Tetrabutylammonium hydroxide solution (40 per cent w/v)

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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and dilute to 100 ml with the solution containing equal volumes of 1.79 per cent w/v of
disodium hydrogen phosphate and 0.78 per cent w/v of sodium dihydrogen phosphate .

Reference solution (a):- Dilute 1.0 ml of the test solution to 50 ml with the mobile phase.
Dilute 5.0 ml of this solution to 100 ml with the mobile phase.

Reference solution (b):- Dilute 1.0 ml of reference solution(a) to 10 ml with the mobile
phase.

Reference solution (c):- A solution containing 0.025 per cent w/v each of 4-aminophenol,
paracetamol WS and chloroacetanilide in methanol. Dilute 1.0 ml of this solution to 250 ml
with mobile phase.
Reference solution (d):- Dissolve 20 mg of 4-nitrophenol in 50 ml of methanol .Dilute 1.0
ml of this solution to 20.0 ml with the mobile phase.

The relative retention time with reference to paracetamol for 4-aminophenol is about 0.8,
for 4-nitrophenol is about 3.0 and chloroacetanilide is about 7.0.
Inject reference solution (c). the test is not valid unless the resolution between the peak due
to 4-aminophenol and paracetamol is not less than 4.0 and the signal-to-noise ratio of the
peak due to chloroacetanilide is not less than 50.
Inject reference solution (a) (b) (c) (d) and the test solution. Run the chromatogram 12
times the retention time of the principal peak. In the chromatogram obtained with test
solution the area of the peak due to chloroacetanilide is not more than 0.2 times the area of
corresponding peak in the chromatogram obtained with reference solution (c) (10 ppm) and
the area of the peak due to 4-aminophenol is not more than the area of the corresponding
peak in the chromatogram

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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6.0 HEAVY METALS: (Limit NMT 10ppm, Method-B)

Lead Standard solution: Following solution prepared as per requirement:-

(1)For 0.1%w/v Pb:Dissolve 400 mg of lead nitrate in water containing 2ml of nitric acid
and add sufficient water to produce 250ml.
(2) For 100 ppm Pb: To 1 volume of above solution to 10volume with water.
(3)For 20 ppm Pb: To 1volume of 100 ppm Pb to 5volume with water
(4) For 10 ppm Pb: To 1 volume of 100 ppm to 10 volumes with water.
(5) For 2 ppm Pb: To 1volume of 10 ppm to 5volume with water.
(6) For 1 ppm Pb: To 1volume of 10 ppm to 10volume with water.

Method B:
Reagent Requirement:
(A)Dilute Acetic Acid.
(B) Dilute Ammonia solution.
(C) Hydrogen Sulphide Solution.

For standard: Into a 50ml nessler cylinder pipette 1ml of lead standard solution as per
requirement and dilute with water to 25ml.Adjust ph 3 to 4 with dilute acetic acid or dilute
ammonia solution, dilute with water to about 35ml and mix.
For Test solution: Weigh in a suitable crucible the quantity of the substances specified in
the individual monograph add sufficient sulphuric acid to wet the sample, ignite it carefully

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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at a low temp until thoroughly charred. Add to the charred mass 2ml of nitric acid and 5
drops of sulphuric acid and heat cautiously until white fumes are no longer evolved, Ignite,
preferably in a muffle furnace, at 500 to 600°C until the carbon is completely burn off, cool
add 4ml of hydrochloric acid, cover, digest on a water bath for 15 minutes, uncover and
slowly evaporate to dryness on a water bath. Moisten the residue with 1 drop of
hydrochloric acid add 10ml of hot water and digest for 2minutes. Add ammonia solution
drop wise until the solution is just alkaline to litmus paper, dilute to 25ml with water and
adjust with dilute acetic acid to ph between 3 to 4. Filter if necessary, rinse the crucible and
wash the filter with 10ml of water, combine with filtrate and washing in to a 50ml Nessler
cylinder dilute with water to about 35ml and mix.
Procedure: To each of the cylinders containing the standard solution and test solution
respectively add 10ml freshly prepared hydrogen sulphide solution mix and dilute with
50ml with water, allow standing for 5minutes and viewing downwards over a white
surface.
Observation: the colour produced with the test solution is not more than intense than that
produced with the standard solution.

7.0 SULPHATED ASH:

Heat a silica crucible to redness for 10minutes, allow it to cool in desiccator and weigh,
transfer to the sample as per specified other wise 1gm of the substances and weigh the
crucible and the content accurately.

Ignite, gently at first, until the substances thoroughly charred, cool, moisten the residue
with 1ml of sulphuric acid, heat gently until the white fumes are no longer evolved and
ignite at 800°C±25°C until all black particles have disappeared. Conduct the ignition in a

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

Page 11 of 14
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place protected from air currents. Allow the crucible to cool, add a few drops of sulphuric
acid and heat. Ignite as before, allow cooling and weighing. Repeat the operation until two
successive weighing do not differ by more than 0.5mg

Calculation:

Weight of residue X 100

Weight of sample

8.0 LOSS ON DRYING: -

Weigh a glass stoppered, shallow weighing bottle that has been dried under the same
conditions to be employed in the determination. Transfer to the bottle the quantity of the
sample about 1.0 g of pallets, cover it and accurately weigh the bottle and the contents.
Distribute the sample as evenly as practicable by gentle sidewise shaking to a depth not
exceeding 10mm. Place the loaded bottle in the drying chamber (oven or desiccator) as
directed in the monograph, remove the stopper and leave it also in the chamber.

Dry the substance at prescribed temperature to constant weight or for the prescribed time or
at prescribed conditions. After drying is completed, open the drying chamber, close the
bottle promptly and allow it to cool to room temperature (where applicable) in a desiccator
before weighing. Weigh the bottle and the contents.

Calculations:

W2 - W3

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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Loss on drying (% w/w): ---------------------- X 100

W2 - W1

W1 = Weight of empty bottle

W2 = Weight of bottle + sample
W3 = Weight of the bottle + sample after drying

Conditions of Loss on drying;

(a) In a desiccator: The drying is carried out over phosphorus pent oxide at atmospheric
pressure and at room temperature.
(b) In vacuum: The drying is carried out over phosphorus pent oxide at a pressure of 1.5 to
2.5 kPa at room temperature.
(c) In vacuum within a specified temperature range: The drying is carried out over
phosphorus pent oxide at a pressure of 1.5 to 2.5 kPa within the temperature range
specified in the monograph.
(d) In an oven within a specified temperature range: The drying is carried out in an
oven within the temperature range specified in the monograph.
(e) Under high vacuum: The drying is carried out over phosphorus pent oxide at a
pressure not exceeding 0.1 kPa at the temperature prescribed in the monograph.

9.0 ASSAY:

Requirement:
1. One 100ml volumetric flask.
2. Two 250ml conical flask.

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

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3.1M sulphuric acid.

4. 2M Hydrochloric acid.
5. Ferroin solution.
6. 0.1M ceric ammonium sulphate.

Procedure: Weigh accurately about 500mg and dissolve in a mixture of 10ml of water and
50ml of sulphuric acid. Boil under a reflux condenser for one hour, cool and dilute to
100ml with water. To 20ml of solution add 40ml of water, 40gm of water in the form of ice,
15 ml of 2M hydrochloric acid and 0.1 ml of ferroin solution and titrate with 0.1M ceric
ammonium sulphate until a yellow colour is produced. Carry on blank titration.

1 ml of 0.1M ceric ammonium sulphate is equivalent to 0.00756 gm of C8H9NO2.

Calculation:

Vol. consumed of 0.1M Ceric ammonium sulphate x 0.00756x normality x100x100

0.1 x weight of sample taken x 100

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018
 HEALER’S LAB. (UNIT II)
PLOT NO. 33 HPSIDC EXTEN. BADDI, DISTT- SOLAN (H.P.)
QUALITY CONTROL DEPARTMENT
STANDARD TESTING PROCEDURE FOR EXCIPIENT MATERIAL
PARACETAMOL I.P.

STANDARD TESTING PROCEDURE

Page 14 of 14
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HL33/STP/RM/119-04 28.03.2018 27.03.2020

10.0 REVISION HISTORY:

Revision Number Date of Revised Reason for Revision Remark

00 ----------- New STP --------
01 31.03.2012 Due to Review O.K.
02 02.04.2014 Due to Review/New O.K.
I.P. 2014
03 02.04.2016 Due to Review O.K.
04 28.03.2018 Due to Review/New O.K
I.P. 2018

“END OF THE DOCUMENTS”

PREPARED BY CHECKED BY APPROVED BY

Designation Officer Q.C. Executive Q.C. Manager Q.C.
Name Shiv Kumar Musafir Yadav Rajneesh Kumari
Signature
Date 28.03.2018 28.03.2018 28.03.2018