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    STP Opadry II

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    ShagorShagor
    This document provides the standard test procedure for OPADRY@ Il 85G58921 White, including: 1) Appearance and identification tests to verify the sample is a white powder that matches the reference sample. 2) A color difference test to ensure the sample matches the reference sample. 3) An ash content test to determine the percentage of inorganic residues is between 40.4-54.60% 4) A dispersion test to check for any undispersed material after mixing the sample in water.

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    STP Opadry II

    Uploaded by

    ShagorShagor
    1K views2 pages
    This document provides the standard test procedure for OPADRY@ Il 85G58921 White, including: 1) Appearance and identification tests to verify the sample is a white powder that matches the reference sample. 2) A color difference test to ensure the sample matches the reference sample. 3) An ash content test to determine the percentage of inorganic residues is between 40.4-54.60% 4) A dispersion test to check for any undispersed material after mixing the sample in water.

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    This document provides the standard test procedure for OPADRY@ Il 85G58921 White, including: 1) Appearance and identification tests to verify the sample is a white powder that matches the reference sample. 2) A color difference test to ensure the sample matches the reference sample. 3) An ash content test to determine the percentage of inorganic residues is between 40.4-54.60% 4) A dispersion test to check for any undispersed material after mixing the sample in water.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    1K views2 pages

    STP Opadry II

    Uploaded by

    ShagorShagor
    This document provides the standard test procedure for OPADRY@ Il 85G58921 White, including: 1) Appearance and identification tests to verify the sample is a white powder that matches the reference sample. 2) A color difference test to ensure the sample matches the reference sample. 3) An ash content test to determine the percentage of inorganic residues is between 40.4-54.60% 4) A dispersion test to check for any undispersed material after mixing the sample in water.

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    © All Rights Reserved
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    VERITAS PHARMACEUTICALS LIMITED,

    Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

    ffiritas
    STANDARD TEST PROCEDURE
    Name OPADRY@ Il 85G58921 White

    Document No.: TP/1 11 5005/01 lssue Date : 24 Jan2014

    Version No.: 0'l Superseded doc. No.: VRME/O/'I 21 1/001 Review Date : 23 Jan 2017

    Approval of Current Version of the Document


    Name Job Title Siqnature & Date
    Prepared by Md. Monjur Rahman Quality Control Officer t,A*";U
    9t ./it lll)
    Agreed by Md. Tarikul lslam Bossunia Asst. Manager Quality Control
    ffi,*&yllo
    Approved by Md. Moniruzzaman Quality Assurance Manager +rr-^Ot,l).tV

    CONTENT

    1. Appearance
    2. ldentification
    3. Colour difference
    4. Ash content, %
    5. Dispersion (25% in water)
    6. Revision History

    DISTRIBUTION LIST

    .Recetv.e(.lr-g;i,liaiu;iiqoiiAit:1itlrl'

    QC Laboratory 01

    This document is Effeciive from the Date of the Approval"

    WlTH0UTPERMlSSIoNFRoMHEADoFQUALlTYASSURANcEoRH
    DOCUMENT IS STRICTLY PROHIBITED

    IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR
    ROUTINE WORK
    Page 1 of 2
    VERITAS PHARMACEUTICALS LIMITED,
    Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
    ffieritas
    ST ANO ARO TEST PROGEOURE

    Material Name: OPADRY@ ll 85G58921 White

    Doc. No.: TP/1 1 15005/01 Version: 01 Prepared By: \zt*-<r/, Approved er' ffii. t'
    1. Description
    Procedure:

    Take about 1 gm of sample in a watch glass and observe for its physical appearance, color, etc, using a white background.

    Limit: A white powder.


    2. ldentification
    Procedure:
    Sample preparation: Weigh 1 to 2 mg of the sample and weigh 300 to 400 mg of fine dry powder of potassium bromide.
    Carefully grind the mixture, spread it uniformly in a suitable die, and submit it to a pressure of about B0 KN. Transfer the disc
    into the sample holder cup and record the IR spectrum.

    Standard preparation: Weigh 1 to 2 mg of the Opadry White (85G68918) Reference Sample and weigh 300 to 400 mg of
    potass\um brom\de. Careiu\ gr\nd the m\xture, spread \t unitorm\y \n a su\\ab\e d\e, and subm\t\t to a pressure of about B0 KN.
    Transfer the disc into the sample holder cup and record the lR spectrum.
    Acceptance criteria: The infrared absorption spectrum of sample is concordant with the spectrum obtained from Opadry White
    (85G6891 B) Reference Sample.

    3. Colour Difference
    Take about 1 g of sample and 1 g of reference sample in two watch glasses and observe for their color.

    Limit: Visually matched to Reference Sample.

    4. Ash Content
    Dry a weighing crucible in a muffle furnace at 600"C for 30 minutes. Place it in desiccators, allow cooling and weighing.
    Accurately weigh about 1.0 g of dried sample in the crucible and ignite it in the furnace. .Rembve the crucible and allow cooling
    in desiccators and reweigh. Calculate the ash content using the following formula:
    Calculation:
    (W1-W2)x100
    (w1-c)

    Where, C = Weight of the crucible (in g)


    W1 = Weight of the crucible and sample before ignition (in g).
    W2 = Weight of the crucible and the sample after ignition (in g).

    Limit: 40.4 to 54,60% w/w

    5. Dispersion

    Take 2.5 g of the sample in 10 ml of water and stire the mixture for 10 minutes.

    Limit: No undispersed material

    6. Revision History

    Document No. Version No Date Reason


    vRME/O/1211l001 00 Jan2012 lnitial procedure for analysis of Opadry White (B5G6B91B)

    TP/1 1 1 5005/01 01 Jan 2014 To detail the procedure for analysis of Opadry White (85G68918)

    IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
    Page2 of 2

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