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    STP of Etratab Bolus

    Uploaded by

    Bejoy Karim
    The document provides specifications for Etratab Vet tablets produced by Ethical Drugs Ltd. including: 1) The tablets should be yellow, oblong shaped with 'EDL' embossed on one side and a break line on the other. Each tablet contains 500mg of oxytetracycline. 2) Tests are defined to check the tablet description, identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, packaging and storage conditions. 3) The test procedure document gives details on how to test the tablets against the specifications including testing identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, leak testing, drug content

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

    STP of Etratab Bolus

    Uploaded by

    Bejoy Karim
    254 views5 pages
    The document provides specifications for Etratab Vet tablets produced by Ethical Drugs Ltd. including: 1) The tablets should be yellow, oblong shaped with 'EDL' embossed on one side and a break line on the other. Each tablet contains 500mg of oxytetracycline. 2) Tests are defined to check the tablet description, identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, packaging and storage conditions. 3) The test procedure document gives details on how to test the tablets against the specifications including testing identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, leak testing, drug content

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    STP of Etratab Bolus

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    The document provides specifications for Etratab Vet tablets produced by Ethical Drugs Ltd. including: 1) The tablets should be yellow, oblong shaped with 'EDL' embossed on one side and a break line on the other. Each tablet contains 500mg of oxytetracycline. 2) Tests are defined to check the tablet description, identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, packaging and storage conditions. 3) The test procedure document gives details on how to test the tablets against the specifications including testing identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, leak testing, drug content

    Copyright:

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

    STP of Etratab Bolus

    Uploaded by

    Bejoy Karim
    The document provides specifications for Etratab Vet tablets produced by Ethical Drugs Ltd. including: 1) The tablets should be yellow, oblong shaped with 'EDL' embossed on one side and a break line on the other. Each tablet contains 500mg of oxytetracycline. 2) Tests are defined to check the tablet description, identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, packaging and storage conditions. 3) The test procedure document gives details on how to test the tablets against the specifications including testing identification, average weight, uniformity of weight, loss on drying, dimensions, hardness, leak testing, drug content

    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
    IN-HOUSE SPECIFICATIONS OF FINISHED PRODUCTS
    Dept. Document No. ID Code Effective Date Version No. Page
    Quality Control QC/SPE/FP003 FP003 01.01.17 01 1 of 1

    Title : SPECIFICATION OF ETRATAB VET TABLET

    TEST : LIMIT
    01. DESCRIPTION : A yellow colored, oblong shape tablets having embossed
    ‘EDL’ on one side and a break line on another side.
    02. IDENTIFICATION : Test must be positive for Oxytetracycline Hydrochloride

    03. AVERAGE WEIGHT : 1420.0 mg  1.0%

    04. UNIFORMITY OF WEIGHT : As per BP

    05. LOSS ON DRYING : 4.0% to 5.0%


    06. LENGTH : 23.5 to 23.6 mm
    07. WIDTH : 12.7 to 12.8 mm
    08. THICKNESS : 6.8 to 6.9 mm
    09. HARDNESS : 3.0 to 5.0 Kg/cm2
    10. PACKING : 3  6’s Blister Strip in a box.
    11. STORAGE : Keep in a cool and dry place protected from light.
    12. STRENGTH : Each bolus contains Oxytetracycline (as Oxytetracycline
    Hydrochloride) BP(vet) 500 mg
    13. ASSAY : 90.0 to 110.0% of labeled amount of Oxytetracycline

    …………………… …………………… ………………………


    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/FP003 FP003 01.01.17 01 1 of 3

    Title : TEST PROCEDURE OF ETRATAB VET TABLET

    01. DESCRIPTION : A yellow colored, oblong shape tablets having embossed


    ‘EDL’ on one side and a break line on another side.

    02. IDENTIFICATION : The UV/VIS absorption spectrum of the assay preparation is


    concordant with the spectrum of the Oxytetracycline
    Hydrochloride Working Standard as in the assay.

    03. AVERAGE WEIGHT : 1420.0 mg  1.0%


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

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

    04. UNIFORMITY OF WEIGHT : Weigh 20 tablets 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 : 4.0% to 5.0%
    Powder 5 tablets and take 1 gm of powder. Determine the LOD
    at 105º C by using a Digital Moisture Analyzer.

    06. LENGTH : 23.5 to 23.6 mm


    Check the length by using a Digital Slide Calipers or equivalent.
    07. WIDTH : 12.7 to 12.8 mm
    Check the width by using a Digital Slide Calipers or equivalent.
    08. THICKNESS : 6.8 to 6.9 mm
    Check the thickness by using a Digital Slide Calipers or equivalent.
    09. HARDNESS : 3.0 to 5.0 Kg/cm2
    Collect 10 tablets and check the hardness of the tablets 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/FP003 FP003 01.01.17 01 2 of 3

    Title : TEST PROCEDURE OF ETRATAB VET TABLET

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

    11. STRENGTH : Each tablet contains Oxytetracycline (as Oxytetracycline


    Hydrochloride) BP(vet) 500 mg
    12. ASSAY : 90.0 to 110.0% of labeled amount of Oxytetracycline

    ASSAY : BY SPECTROPHOTOMETRY
    PROCEDURE:

    01. Std. Soln. :


    Dissolve 54.0 mg of Oxytetracycline Hydrochloride WS in 60 ml of 0.1 M Hydrochloric Acid
    and dilute to 100 ml with the same solvent. Dilute 2 ml of the resulting solution to 100 ml with
    0.1 M Hydrochloric Acid.

    02. Sample Soln. :


    Weigh and powder 10 tablets and dissolve powder equivalent to 50.0 mg of Oxytetracycline in 60
    ml of 0.1 M Hydrochloric Acid and shake for 30 minutes. Dilute to 100 ml with the same solvent
    and filter. Dilute 2 ml of the filtrate to 100 ml with 0.1 M Hydrochloric Acid.
    03. Measure the absorbances for the Standard and Sample solutions at 271 nm using 0.1 M
    Hydrochloric Acid 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/FP003 FP003 01.01.17 01 3 of 3

    Title : TEST PROCEDURE OF ETRATAB VET TABLET

    Content of Oxytetracycline, in mg /tablet

    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 tablet
    …………………… …………………… ………………………
    Written by Checked by Approved by

    QC Officer Sr. QC Officer QC Manager


    Date : Date : Date :

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