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/FP031 FP031 01.01.17 01 1 of 1

Title : SPECIFICATION OF TRIXIM-400 CAPSULE

TEST : LIMIT
01. DESCRIPTION : A black OP/orange OP ‘0’ size hard gelatin capsule filled with
crystalline powder.

02. IDENTIFICATION : Test must be positive for Cefixime Trihydrate

03. AVERAGE FILLED WEIGHT : 525.0 mg  1.0%

04. UNIFORMITY OF WEIGHT : As per BP

05. AVERAGE WT. OF SHELL : 86.0 to 106.0 mg

06. WATER CONTENT : 9.0% to 12.0%

07. DISINTEGRATION TIME : NMT 30 minutes
08. LEAK TEST : Should be 100% leak proof.
09. PACKING : 1  6’s Alu/Alu Blister Strip in a box.
10. STORAGE : Keep in a cool and dry place protected from light.
11. STRENGTH : Each capsule contains Cefixime (as Cefixime Trihydrate)
BP 400 mg

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

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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/FP031 FP031 01.01.17 01 1 of 3

Title : TEST PROCEDURE OF TRIXIM-400 CAPSULE

01. DESCRIPTION : A black OP/orange OP ‘0’ size hard gelatin capsule filled with
crystalline powder.
02. IDENTIFICATION : The UV/VIS absorption spectrum of the assay preparation is
concordant with the spectrum of the Cefixime Trihydrate
Working Standard as in the assay.
03. AVERAGE FILLED WEIGHT : 525.0 mg  1.0%
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 : 86.0 to 106.0 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/FP031 FP031 01.01.17 01 2 of 3

Title : TEST PROCEDURE OF TRIXIM-400 CAPSULE

06. WATER CONTENT : 9.0% to 12.0%

Open 10 capsules and mix powder. Take 50 mg 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 Cefixime (as Cefixime Trihydrate) BP 400 mg

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

ASSAY : BY SPECTROPHOTOMETRY
PROCEDURE:
01. Std. Soln. :
Dissolve 56.0 mg of Cefixime Trihydrate WS in 30 ml of methanol and dilute to 50 ml with the
same solvent. Dilute 2 ml of the resulting solution 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/FP031 FP031 01.01.17 01 3 of 3

Title : TEST PROCEDURE OF TRIXIM-400 CAPSULE

02. Sample Soln. :

To a quantity of the mixed contents of 20 capsules containing the equivalent of 50 mg of
Cefixime add 30 ml of methanol, shake for 30 minutes and dilute to 50 ml with the same
solvent and filter. Dilute 2 ml of the filtrate to 100 ml with water.
03. Measure the absorbances for the Standard and Sample solutions at 254 nm using water as blank.
Calculate the content by the formula:

Content of Cefixime, in mg /Capsule

AU WS
= ---------  ---------  F  P  Av. 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
Av. Wt. = Average weight of the capsule
…………………… …………………… ………………………
Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager

Date : Date : Date :