eTHiCaL DruGS LTD.

SIDDHIRGANJ, NARAYANGANJ
IN-HOUSE SPECIFICATIONS OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/SPE/FP019 FP019 01.01.17 01 1 of 1

Title : SPECIFICATION OF EMOXIL 250 CAPSULE

TEST : LIMIT
01. DESCRIPTION : A black OP/orange OP ‘2’ size hard gelatin capsule filled with
white crystalline powder.
02. IDENTIFICATION : Test must be positive for Amoxicillin Trihydrate

03. AVERAGE FILLED WEIGHT : 294.0 mg  1.0%

04. UNIFORMITY OF WEIGHT : As per BP

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

06. WATER CONTENT : 11.5% to 14.5%

07. DISINTEGRATION TIME : NMT 30 minutes
08. LEAK TEST : Should be 100% leak proof.
09. PACKING : 10  10’s Blister Strip in a box.
10. STORAGE : Keep in a cool and dry place protected from light.
11. STRENGTH : Each capsule contains Amoxicillin (as Amoxicillin Trihydrate)
BP 250 mg

12. ASSAY : 90.0 to 110.0% of labeled amount of Amoxicillin

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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/FP019 FP019 01.01.17 01 1 of 4

Title : TEST PROCEDURE OF EMOXIL 250 CAPSULE

01. DESCRIPTION : A black OP/orange OP ‘2’ size hard gelatin capsule filled with
white crystalline powder.

02. IDENTIFICATION : Take powder containing about 10 mg of Amoxicillin Trihydrate and

add 1 ml of water and mix. Add 2 ml of Potassium Cupritartrate
solution and then add 6 ml of water. A magenta color is
immediately produced.
03. AVERAGE FILLED WEIGHT : 294.0 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/FP019 FP019 01.01.17 01 2 of 4

Title : TEST PROCEDURE OF EMOXIL 250 CAPSULE

06. WATER CONTENT : 11.5 to 14.5%

Open 10 capsules and mix powder. Take 50mg of powder and determine
water content by using a Digital Karl Fischer Titrator.
07. DT : NMT 30 minutes.
Apparatus : Tablet Disintegration Test Machine
Introduce one capsule into each tube, add a disc to each tube. Suspend the
assembly in the beaker containing water, maintained the temperature at
37 ± 2°C. Operate the apparatus for the specified time. Remove the
assembly from the liquid. The capsules pass the test if all six have
disintegrated.
08. 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.
09. STRENGTH : Each capsule contains Amoxicillin (as Amoxicillin Trihydrate)
BP 250 mg

10. ASSAY : 90.0 to 110.0% of labeled amount of Amoxicillin

ASSAY : BY SPECTROPHOTOMETRY
REAGETS:
1) Imidazole-Mercury Reagent:
 Dissolve 8.25 gm of Imidazole in 60 ml of water and add 10 ml of 5M Hydrochloric Acid. Add
10 ml of 0.27% w/v solution of Mercury (II) chloride dropwisely. Adjust pH 6.75 to 6.85 with
5 M Hydrochloric Acid (about 4 ml). Dilute to 100 ml with water.
]

…………………… …………………… ………………………

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/FP019 FP019 01.01.17 01 3 of 4

Title : TEST PROCEDURE OF EMOXIL 250 CAPSULE

1I) 0.27% Mercury (II) Chloride Solution:

Dissolve 270 mg of Mercury (II) Chloride in water and dilute to100 ml with the same solvent.
I1I) Acetic Anhydride-Dioxan Solution:
Mix 1 ml of Acetic Anhydride to 50 ml of 1, 4 Dioxan.

IV) Boric Buffer pH 9.0:

Dissolve 620 mg of Boric Acid in 50 ml of water, adjust to pH 9.0 with 1M Sodium Hydroxide
(about 4.15 ml) and dilute to 100 ml with water.

PROCEDURE:
To a quantity of the mixed contents of 20 capsules containing the equivalent of 150 mg of Amoxicillin
add sufficient water to produce 500 ml, shake for 30 minutes and filter. Transfer 10 ml of the filtrate
to 100 ml volumetric flask. Add 10 ml of Boric buffer pH 9.0 followed by 1 ml of acetic anhydride-
dioxin solution, allow to stand for 5 minutes and add sufficient water to produce 100 ml.
Place two 2-ml quantities of this solution in separated stoppered tubes. To one tube add 10 ml of
Imidazole-mercury reagent, mix, stopper the tube and immerse in a water bath at 60°C for exactly 25
minutes, swirling occasionally.
Remove from the water bath and cool rapidly to 20°C (solution A). To the second tube add 10 ml of
water and mix (solution B).
Without delay measure the absorbances of solutions A and B at the maximum at 325 nm, using in the
reference cell a mixture of 2 ml of water and 10 ml of Imidazole-mercury reagent for solution A and
water for solution B.

Repeat the operation using 170 mg of Amoxicillin Trihydrate Working Standard in place of the
substance being examined. Calculate the content by the formulation:
 Content of Amoxicillin, in mg /Capsule
AUA - AUB WS
= ------------------ ´ --------- ´ F ´ P ´ Av. Wt.
ASA - ASB WU

…………………… …………………… ………………………

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/FP019 FP019 01.01.17 01 4 of 4

Title : TEST PROCEDURE OF EMOXIL 250 CAPSULE

Here,
AUA = Absorbance of the Sample for solution A
AUB = Absorbance of the Sample for solution B
ASA = Absorbance of the Standard for solution A
ASB = Absorbance of the Standard for solution B

WU = Weight of the Sample

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

QC Officer Sr. QC Officer QC Manager

Date : Date : Date :