eTHiCaL DruGS LTD.

SIDDHIRGANJ, NARAYANGANJ
SPECIFICATIONS OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/SPE/FP027 FP027 01.01.17 01 1 of 1

Title : SPECIFICATION OF GASTRIL 20 CAPSULE

TEST : LIMIT
01. DESCRIPTION : A violet TR/natural TR ‘2’ size hard gelatin capsule filled with
White enteric coated spherical pellets.

02. IDENTIFICATION : Test must be positive for Omeprazole

03. AVERAGE FILLED WEIGHT : 324.0 mg  1.0%

04. UNIFORMITY OF WEIGHT : As per BP

05. AVERAGE WT. OF SHELL : 58.0 to 68.0 mg

06. LOSS ON DRYING : NMT 3.0%
07. GASTRO RESISTANCE : NLT 90.0% of Omeprazole should retain in 0.1 M HCl after
2 hours
08. DISSOLUTION IN : NLT 75.0% of Omeprazole should be dissolved in phosphate
PHOPHATE BUFFER pH 6.8 buffer pH 6.8 within 45 minutes.
09. LEAK TEST : Should be 100% leak proof.

10. STRENGTH : Each capsule contains Omeprazole (as enteric coated pellets)
BP 20 mg

11. ASSAY : 90.0 to 110.0% of labeled amount of Omeprazole.

12. PACKING : 10  10’s Alu/Alu Blister Strip in a box.

13. STORAGE : Keep in a cool and dry place protected from light.

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Written by Checked by Approved by
 QC Officer Sr. QC Officer QC Manager
Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP027 FP027 01.01.17 01 1 of 6

Title : TEST PROCEDURE OF GASTRIL 20 CAPSULE

01. DESCRIPTION : A violet TR/natural TR ‘2’ size hard gelatin capsule filled with
white enteric coated spherical pellets.
02. IDENTIFICATION : The UV/VIS absorption spectrum of the assay preparation is
correspondence to the spectrum of the Omeprazole Working
Standard as in the assay.
03. AVERAGE FILLED WEIGHT : 324.0 mg  1%
Weigh an intact capsule. Open the capsule without losing any part
of the shell and remove the contents as completely as possible.
Weigh the shell. The weight of the contents is the difference
between the weighings. Repeat the procedure with another nineteen
capsules. Calculate the average weight as follow:
Total weight
Average weight = -------------------
Number (20)

04. UNIFORMITY OF WEIGHT : Weigh an intact capsule. Open the capsule without losing any part
of the shell and remove the contents as completely as possible.
Weigh the shell. The weight of the contents is the difference
between the weighings. Repeat the procedure with another nineteen
capsules. Determine the average weight. Not more than two of the
individual weights deviate from the average weight by more than
10.0% and none deviates by more than twice of 10.0%.

05. AVERAGE WT. OF SHELL : 58.0 to 68.0 mg

Collect 20 shells randomly, weigh and record. Calculate the
average weight as follow:
Total weight
Average weight = -------------------
Number (20)
 …………………… …………………… ………………………
Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager

Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP027 FP027 01.01.17 01 2 of 6

Title : TEST PROCEDURE OF GASTRIL 20 CAPSULE

06. LOSS ON DRYING : NMT 3.0%

Open 10 capsules and mix powder. Take 50 mg of powder and determine
by using a Digital Moisture Analyzer.
07. GASTRO RESISTANCE : NLT 90.0% of Omeprazole should retain in 0.1 M HCl after 2 hours

Apparatus : Tablet/Capsule Dissolution Test Apparatus

USP Type-I

Medium : 900 ml of 0.1M HCl

Agitation : 100 RPM
Temperature : 37.0 ± 1.0° C
Time : 2 hours

Standard Solution:
Dissolve 20.0 mg of Omeprazole WS in 0.1 M sodium hydroxide and
dilute to 100 ml with the same solvent. Dilute 5 ml of the resulting solution
to100 ml with 0.1 M sodium hydroxide.

Sample Preparation:
Pour 900 ml of 0.1 M HCl in each dissolution flasks, and assemble the
apparatus. Allow the 0.1 M HCl medium to equilibrate to a temperature of
37 ± 1°C. Insert the capsule in each basket and operate the apparatus for
specified time. At the end of 2 hours lift the assembly from the dissolution
flasks. Transfer the pellets to filter paper and dry the pellets by blotting with
filter paper. Transfer the pellets from each basket into 100 ml volumetric
flask and add 60 ml of 0.1 M sodium hydroxide and shake for 30 minutes
and dilute to 100 ml with the same solvent and filter. Dilute 5 ml of the
filtrate to 100 ml with 0.1 M sodium hydroxide.
Procedure:
Measure the absorbances of sample and standard solutions at 305 nm using
0.1 M sodium hydroxide as blank. Calculate the amount of Omeprazole
 retained in 0.1 M HCl in % by the formula:

…………………… …………………… ………………………

Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager

Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP027 FP027 01.01.17 01 3 of 6

Title : TEST PROCEDURE OF GASTRIL 20 CAPSULE

AU WS 5 100 100 Avg. Wt.

= ---------  --------- × ----------- × --------- × --------- × P  ------------ ×100
AS 100 100 WU 5 LC

Here,
AU = Absorbance of the Sample
AS = Absorbance of the Standard

WU = Weight of the Sample

WS = Weight of the standard
LC = Label claim
P = Potency of the Standard used in percentage
Avg. Wt. = Average weight of the capsule

08. DISSOLUTION IN : NLT 75.0% of Omeprazole should be dissolved in phosphate

PHOSPHATE buffer pH 6.8 within 45 minutes.
BUFFER pH 6.8
Apparatus : Tablet/Capsule Dissolution Test Apparatus
USP Type-I

Medium : 900 ml of 0.1M HCl for 2 hours and 900 ml phosphate

buffer pH 6.8

Agitation : 100 RPM

Temperature : 37.0 ± 1.0° C
 Time : 2 hours & 45 minutes

Standard Solution:
Dissolve 20 .0 mg of Omeprazole WS in 0.1 M sodium hydroxide and
dilute to 100 ml with the same solvent. Dilute 5 ml of the resulting solution
to 100 ml with phosphate buffer pH 6.8.

…………………… …………………… ………………………

Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager

Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP027 FP027 01.01.17 01 4 of 6

Title : TEST PROCEDURE OF GASTRIL 20 CAPSULE

Sample Preparation:
Pour 900 ml of 0.1 M HCl in each dissolution flasks, and assemble the
apparatus. Allow the 0.1 M HCl medium to equilibrate to a temperature of
37 ± 1°C. Insert the capsule in each basket and operate the apparatus for
specified time. At the end of 2 hours lift the assembly from the dissolution
flasks. Discard the dissolution medium (0.1M HCl) from each flask and pour
900 ml of phosphate buffer pH 6.8 into each flask, equilibrate to a
temperature of 37 ± 1°C. Run the apparatus for 45 minutes. Collect 10 ml
of sample from each flask and dilute to 25 ml with phosphate buffer
pH 6.8 and filter.
Procedure:
Measure the absorbances of sample and standard solutions at 305 nm using
Phosphate buffer pH 6.8 as blank. Calculate the amount of Omeprazole
dissolved in phosphate buffer in % by the formula:

AU WS 5 900 25 Avg. Wt.

= ---------  --------- × ----------- × --------- × --------- × P  ------------ ×100
AS 100 100 WU 10 LC

Here,
AU = Absorbance of the Sample
AS = Absorbance of the Standard

WU = Weight of the Sample

 WS = Weight of the standard
LC = Label claim
P = Potency of the Standard used in percentage
Avg. Wt. = Average weight of the capsule

…………………… …………………… ………………………

Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager

Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP027 FP027 01.01.17 01 5 of 6

Title : TEST PROCEDURE OF GASTRIL 20 CAPSULE

09. LEAK TEST : Should be 100.0% leak proof.

Submerge 5 Strips in water containing 0.2% w/v methylene blue
or any suitable color in leak test Apparatus. Maintain the strips
below the surface of water by means of a suitable device such as metal
disc or desiccator shelf. Apply the vacuum of 380 mm of mercury for
at least 2 minutes in the desiccator. Release the pressure slowly ﴾taking at
least 30 seconds﴿ and take out the strips. Wipe them to dry with clean dry
lint free cloth or tissue paper. De-foil the blister strips and observe for
blue spots/moistness/water inside the pockets.
If blue spots / moistness or water is not found inside the pockets, strips
are passed for the test.
10. STRENGTH : Each capsule contains Omeprazole (as enteric coated pellets)
BP 20 mg

11. ASSAY : 90.0 to 110.0% of labeled amount of Omeprazole

ASSAY : BY SPECTROPHOTOMETRY
PROCEDURE:
01. Std. Soln. :
Dissolve 20.0 mg of Omeprazole WS in 50 ml of 0.1 M sodium hydroxide and dilute to 100 ml
with the same solvent. Dilute 5 ml of the resulting solution to 100 ml with 0.1 M sodium
 hydroxide.
02. Sample Soln. :
To a quantity of the mixed contents of 20 capsules containing the equivalent of 20 mg of
Omeprazole add 50 ml of 0.1 M sodium hydroxide, shake for 30 minutes and dilute to 100 ml
with the same solvent and filter. Dilute 5 ml of the filtrate to 100 ml with 0.1 M sodium hydroxide.
03. Measure the absorbances for the Standard and Sample solutions at 305 nm using 0.1 M sodium
hydroxide as blank. Calculate the content by the formula:

…………………… …………………… ………………………

Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager

Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP027 FP027 01.01.17 01 6 of 6

Title : TEST PROCEDURE OF GASTRIL 20 CAPSULE

Content of Omeprazole, in mg /Capsule

AU WS
= ---------  ---------  F  P  Avg. Wt.
AS WU

Here,
AU = Absorbance of the Sample
AS = Absorbance of the Standard

WU = Weight of the Sample

WS = Weight of the Standard
F = Dilution factor
P = Potency of the Standard used in percentage
Avg. Wt. = Average weight of the capsule
…………………… …………………… ………………………
Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager

Date : Date : Date :