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    STP of Ambeet Capsule NS

    Uploaded by

    Bejoy Karim
    The document provides specifications and test procedures for Ambeet capsules. It lists 11 tests including description, identification, average filled weight, uniformity of weight, dissolution, leak test, and assay. The tests ensure the capsules contain the correct ingredients and dosage and meet quality standards.

    Copyright:

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

    STP of Ambeet Capsule NS

    Uploaded by

    Bejoy Karim
    106 views6 pages
    The document provides specifications and test procedures for Ambeet capsules. It lists 11 tests including description, identification, average filled weight, uniformity of weight, dissolution, leak test, and assay. The tests ensure the capsules contain the correct ingredients and dosage and meet quality standards.

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    STP of Ambeet Capsule NS

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    The document provides specifications and test procedures for Ambeet capsules. It lists 11 tests including description, identification, average filled weight, uniformity of weight, dissolution, leak test, and assay. The tests ensure the capsules contain the correct ingredients and dosage and meet quality standards.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    106 views6 pages

    STP of Ambeet Capsule NS

    Uploaded by

    Bejoy Karim
    The document provides specifications and test procedures for Ambeet capsules. It lists 11 tests including description, identification, average filled weight, uniformity of weight, dissolution, leak test, and assay. The tests ensure the capsules contain the correct ingredients and dosage and meet quality standards.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 6

    eTHiCaL DruGS LTD.

    SIDDHIRGANJ, NARAYANGANJ
    SPECIFICATIONS OF FINISHED PRODUCTS
    Dept. Document No. ID Code Effective Date Version No. Page
    Quality Control QC/SPE/FP050 FP050 01.01.17 01 1 of 1

    Title : SPECIFICATION OF AMBEET CAPSULE

    TEST : LIMIT
    01. DESCRIPTION : A green TR/natural TR ‘1’ size hard gelatin capsule filled with
    white SR spherical pellets.

    02. IDENTIFICATION : Test must be positive for Ambroxol HCl

    03. AVERAGE FILLED WEIGHT : 431.0 mg  1.0%

    04. UNIFORMITY OF WEIGHT : As per BP

    05. AVERAGE WT. OF SHELL : 69.0 to 85.0 mg


    06. LOSS ON DRYING : NMT 3.0%

    07. DISSOLUTION : Apparatus : Tablet/Capsule Dissolution Test Apparatus USP type-I


    Medium
    [
    : 900 ml phosphate buffer pH 6.8
    Agitation : 50 RPM
    Temperature : 37.0 ± 1.0° C
    1st Hour : 10.0% to 35.0%
    4th Hour : 25.0% to 55.0%
    8th Hour : 45.0% to 75.0%

    08. LEAK TEST : Should be 100% leak proof.

    09. STRENGTH : Each capsule contains Ambroxol HCl SR pellets equivalent to


    75.0 mg of Ambroxol HCl

    10. ASSAY : 90.0 to 110.0% of labeled amount of Ambroxol HCl


    11. PACKING : 3  10’s PVDC Blister Strip in a box.
    12. 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/FP050 FP050 01.01.17 01 1 of 6

    Title : TEST PROCEDURE OF AMBEET CAPSULE

    01. DESCRIPTION : A green TR/natural TR ‘1’ size hard gelatin capsule filled with
    white SR spherical pellets.
    02. IDENTIFICATION : The UV/VIS absorption spectrum of the assay preparation is
    correspondence to the spectrum of the Ambroxol HCl Working
    Standard as in the assay.
    03. AVERAGE FILLED WEIGHT : 431.0 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
    7.5% and none deviates by more than twice of 7.5%.

    05. AVERAGE WT. OF SHELL : 69.0 to 85.0 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/FP050 FP050 01.01.17 01 2 of 6

    Title : TEST PROCEDURE OF AMBEET CAPSULE

    06. LOSS ON DRYING : NMT 3.0%


    Open 10 capsules and mix pellets. Take 1 gm of pellets and determine
    by using a Digital Moisture Analyzer.

    07. DISSOLUTION : Apparatus : Tablet/Capsule Dissolution Test Apparatus USP type-I


    Medium : 900 ml phosphate buffer pH 6.8
    [

    Agitation : 50 RPM
    Temperature : 37.0 ± 1.0° C
    1st Hour : 10.0% to 35.0%
    4th Hour : 25.0% to 55.0%
    8th Hour : 45.0% to 75.0%

    Standard Solution:
    Dissolve 75.0 mg of Ambroxol HCl WS in methanol and dilute to
    100 ml with the same solvent. Dilute 2 ml of the resulting solution
    to 50.0 ml with Phosphate buffer pH 6.8 .

    Sample Preparation:
    Pour 900 ml of Phosphate buffer pH 6.8 in each dissolution flasks, and
    assemble the apparatus. Allow the Phosphate buffer pH 6.8 medium
    to equilibrate to a temperature of 37 ± 1°C. Put capsule in each basket
    and operate the apparatus for 1 hour. At the end of 1 hour collect 10 ml
    of sample from the dissolution flasks. Continue the operation for 8 hours.
    After 4 hours and 8 hours collect the sample as same as 1 hour.
    Dilute 10 ml of the each sample for different periods to 25.0 ml
    with Phosphate buffer pH 6.8 respectively and filter.

    Measure the absorbances of Standard and Sample solutions at 245 nm


    using Phosphate buffer pH 6.8 as blank. Calculate the amount of Ambroxol HCl
    dissolved in phosphate buffer pH 6.8 for different time intervals in % by the
    formula:
    AU WS 2 900 25 Avg. Wt.
    = ---------  --------- × ----------- × --------- × --------- × P  ------------ ×100
    AS 100 50 WU 10 LC

    …………………… …………………… ………………………


    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/FP050 FP050 01.01.17 01 4 of 6

    Title : TEST PROCEDURE OF AMBEET CAPSULE

    Here,
    AU = Absorbance of the Sample
    AS = Absorbance of the Standard

    WU = Weight of the Sample


    WS = Weight of the standard
    LC = Label Claim
    P = Potency of the Standard used in percentage
    Avg. Wt. = Average weight of the capsule
    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 Ambroxol HCl SR pellets equivalent to
    75.0 mg of Ambroxol HCl
    10. ASSAY : 90.0 to 110.0% of labeled amount of Ambroxol HCl
    ASSAY : BY SPECTROPHOTOMETRY
    PROCEDURE:
    01. Std. Soln. :
    Dissolve 100.0 mg of Ambroxol HCl WS in 50 ml of methanol and dilute to 100 ml
    with the same solvent. Dilute 2 ml of the resulting solution to 50.0 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/FP050 FP050 01.01.17 01 4 of 6

    Title : TEST PROCEDURE OF AMBEET CAPSULE

    02. Sample Soln. :


    To a quantity of the mixed contents of 20 capsules containing the equivalent of 100 mg of
    Ambroxol HCl add 50 ml of methanol, shake for 30 minutes and dilute to 100 ml with the
    same solvent and filter. Dilute 2 ml of the filtrate to 50 ml with water.
    03. Measure the absorbances for the Standard and Sample solutions at 245 nm using water
    as blank. Calculate the content by the formula:

    Content of Ambroxol HCl, in mg /Capsule

    AU WS
    = ---------  ---------  F  P  Avg. 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
    Avg. 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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