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    STP of Trixim 400 Capsule

    Uploaded by

    Bejoy Karim
    This document provides specifications and test procedures for Trixim-400 capsules produced by Ethical Drugs Ltd. The summary is as follows: 1. The specifications include description, identification, average filled weight, uniformity of weight, average weight of shell, water content, disintegration time, leak test, packing, storage, strength, and assay. 2. The test procedures describe how to test for description, identification, average filled weight, uniformity of weight, average weight of shell, water content, disintegration time, leak test, strength, and assay by spectrophotometry. 3. The assay procedure involves preparing standard and sample solutions, measuring absorbances at 254 nm using water as

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    STP of Trixim 400 Capsule

    Uploaded by

    Bejoy Karim
    132 views5 pages
    This document provides specifications and test procedures for Trixim-400 capsules produced by Ethical Drugs Ltd. The summary is as follows: 1. The specifications include description, identification, average filled weight, uniformity of weight, average weight of shell, water content, disintegration time, leak test, packing, storage, strength, and assay. 2. The test procedures describe how to test for description, identification, average filled weight, uniformity of weight, average weight of shell, water content, disintegration time, leak test, strength, and assay by spectrophotometry. 3. The assay procedure involves preparing standard and sample solutions, measuring absorbances at 254 nm using water as

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    This document provides specifications and test procedures for Trixim-400 capsules produced by Ethical Drugs Ltd. The summary is as follows: 1. The specifications include description, identification, average filled weight, uniformity of weight, average weight of shell, water content, disintegration time, leak test, packing, storage, strength, and assay. 2. The test procedures describe how to test for description, identification, average filled weight, uniformity of weight, average weight of shell, water content, disintegration time, leak test, strength, and assay by spectrophotometry. 3. The assay procedure involves preparing standard and sample solutions, measuring absorbances at 254 nm using water as

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    132 views5 pages

    STP of Trixim 400 Capsule

    Uploaded by

    Bejoy Karim
    This document provides specifications and test procedures for Trixim-400 capsules produced by Ethical Drugs Ltd. The summary is as follows: 1. The specifications include description, identification, average filled weight, uniformity of weight, average weight of shell, water content, disintegration time, leak test, packing, storage, strength, and assay. 2. The test procedures describe how to test for description, identification, average filled weight, uniformity of weight, average weight of shell, water content, disintegration time, leak test, strength, and assay by spectrophotometry. 3. The assay procedure involves preparing standard and sample solutions, measuring absorbances at 254 nm using water as

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    © All Rights Reserved
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    Download as doc, pdf, or txt
    of 5

    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.

    …………………… …………………… ………………………


    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 :

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