Scribd Logo
Upload

Welcome to Scribd!

  • 99 views

    STP of Triben-P Bolus NS

    Uploaded by

    Bejoy Karim
    The document provides the specifications and test procedures for Triben-P Vet Bolus, an off-white elongated bolus containing Triclabendazole, including limits for description, identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, strength, assay, packaging and storage. Tests include description, identification, weight variation, loss on drying, dimensions, hardness, leak testing, drug content and assay. The assay procedure requires weighing and powdering boluses, dissolving in acetic acid and titrating with perchloric acid to determine the percentage of the labeled amount of Triclabendazole.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd

    STP of Triben-P Bolus NS

    Uploaded by

    Bejoy Karim
    99 views5 pages
    The document provides the specifications and test procedures for Triben-P Vet Bolus, an off-white elongated bolus containing Triclabendazole, including limits for description, identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, strength, assay, packaging and storage. Tests include description, identification, weight variation, loss on drying, dimensions, hardness, leak testing, drug content and assay. The assay procedure requires weighing and powdering boluses, dissolving in acetic acid and titrating with perchloric acid to determine the percentage of the labeled amount of Triclabendazole.

    Original Title

    STP of Triben-P Bolus NS

    Copyright

    © © All Rights Reserved

    Available Formats

    DOC, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document provides the specifications and test procedures for Triben-P Vet Bolus, an off-white elongated bolus containing Triclabendazole, including limits for description, identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, strength, assay, packaging and storage. Tests include description, identification, weight variation, loss on drying, dimensions, hardness, leak testing, drug content and assay. The assay procedure requires weighing and powdering boluses, dissolving in acetic acid and titrating with perchloric acid to determine the percentage of the labeled amount of Triclabendazole.

    Copyright:

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

    STP of Triben-P Bolus NS

    Uploaded by

    Bejoy Karim
    The document provides the specifications and test procedures for Triben-P Vet Bolus, an off-white elongated bolus containing Triclabendazole, including limits for description, identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, strength, assay, packaging and storage. Tests include description, identification, weight variation, loss on drying, dimensions, hardness, leak testing, drug content and assay. The assay procedure requires weighing and powdering boluses, dissolving in acetic acid and titrating with perchloric acid to determine the percentage of the labeled amount of Triclabendazole.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 5

    eTHiCaL DruGS LTD.

    SIDDHIRGANJ, NARAYANGANJ
    SPECIFICATIONS OF FINISHED PRODUCTS
    Dept. Document No. ID Code Effective Date Version No. Page
    Quality Control QC/SPE/FP021 FP021 01.01.17 01 1 of 1

    Title : SPECIFICATION OF TRIBEN-P VET BOLUS

    TEST : LIMIT
    01. DESCRIPTION : An off white elongated bolus having embossed ‘ETHICAL’ on
    one side and a break line on another side.
    02. IDENTIFICATION : Test must be positive for Triclabendazole.

    03. AVERAGE WEIGHT : 4200.0 mg  1.0%

    04. UNIFORMITY OF WEIGHT : As per BP

    05. LOSS ON DRYING : 3.5% to 4.5%


    06. LENGTH : 39.0 to 39.1 mm
    07. WIDTH : 15.0 to 15.1 mm
    08. THICKNESS : 8.0 to 8.1 mm
    09. HARDNESS : 3.0 to 6.0 Kg/cm2
    12. STRENGTH : Each bolus contains Triclabendazole INN

    13. ASSAY : 90.0 to 110.0% of labeled amount of Triclabendazole

    10. PACKING : 5  4’s Blister Strip in a box.


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

    …………………… …………………… ………………………


    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/FP021 FP021 01.01.17 01 1 of 4

    Title : TEST PROCEDURE OF TRIBEN-P VET BOLUS

    01. DESCRIPTION : An off white elongated bolus having embossed ‘ETHICAL’ on


    one side and a break line on another side.

    02. IDENTIFICATION : In-house

    03. AVERAGE WEIGHT : 4200.0 mg  1.0%


    Collect 20 bolus randomly, weigh and record. Calculate the
    average weight as follow:

    Total weight
    Average weight = -------------------
    Number (20)

    04. UNIFORMITY OF WEIGHT : Weigh 20 bolus selected at random and determine the average
    weight. Not more than two of the individual weights deviate from
    the average weight by more than 5.0% and none deviates by more
    than twice of 5.0%.
    05. LOSS ON DRYING : 3.5% to 4.5%
    Powder 5 bolus and take 1 gm of powder. Determine the LOD
    at 105º C by using a Digital Moisture Analyzer.

    06. LENGTH : 39.0 to 39.1 mm


    Check the length by using a Digital Slide Calipers or equivalent.
    07. WIDTH : 15.0 to 15.1 mm
    Check the width by using a Digital Slide Calipers or equivalent.
    08. THICKNESS : 8.0 to 8.1 mm
    Check the thickness by using a Digital Slide Calipers or equivalent.
    09. HARDNESS : 3.0 to 6.0 Kg/cm2
    Collect 5 bolus and check the hardness of the bolus by using
    suitable hardness tester and record.
    …………………… …………………… ………………………
    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/FP021 FP021 01.01.17 01 2 of 4

    Title : TEST PROCEDURE OF TRIBEN-P VET BOLUS

    10. LEAK TEST : 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 pockets.
    If blue spots / moistness or water is not found inside the pockets, strips
    are passed for the test.

    11. STRENGTH : Each bolus contains Triclabendazole INN 900 mg

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

    PROCEDURE:

    Weigh and powder 10 bolus. Transfer powder equivalent to 200 mg of Triclabendazole in a conical
    flask and add 40 ml of Glacial Acetic Acid and shake to dissolve. Then add 2 drops of Crystal violet
    solution as indicator. Titrate with 0.1 M Perchloric Acid V to the end point.

    Each ml of 0.1M Perchloric Acid VS is equivalent to 35.97 mg of Triclabendazole


    Calculate the content by the formula:
    Content of Triclabendazole, in mg /Bolus

    V × F× 35.97
    = --------------------------- ´ Av. Wt.
    Wt.

    …………………… …………………… ………………………


    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/FP021 FP021 01.01.17 01 3 of 4

    Title : TEST PROCEDURE OF TRIBEN-P VET BOLUS

    Here,
    V = Consumed Volume of 0.1 M Perchloric Acid

    F = Factor of the Volumetric Solution


    Wt. = Weight of sample taken
    Av. Wt. = Average weight of bolus
    …………………… …………………… ………………………
    Written by Checked by Approved by

    QC Officer Sr. QC Officer QC Manager


    Date : Date : Date :

    You might also like