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    Psychotropics India Limited: Plot No. - 46 & 49, Sector - 6A, IIE, SIDCUL, Haridwar (U.K.)

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    markandey gupta
    The document describes a protocol for cleaning validation involving recovering drug from swabs sampled from stainless steel plates spiked with different concentrations of drug solution. The protocol involves spiking plates with different concentrations of drug solution, sampling with swabs, extracting drug from swabs, measuring detector response of extracts, and calculating drug content and recovery percentage.

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    Psychotropics India Limited: Plot No. - 46 & 49, Sector - 6A, IIE, SIDCUL, Haridwar (U.K.)

    Uploaded by

    markandey gupta
    68 views1 page
    The document describes a protocol for cleaning validation involving recovering drug from swabs sampled from stainless steel plates spiked with different concentrations of drug solution. The protocol involves spiking plates with different concentrations of drug solution, sampling with swabs, extracting drug from swabs, measuring detector response of extracts, and calculating drug content and recovery percentage.

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    ANNEX V

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    The document describes a protocol for cleaning validation involving recovering drug from swabs sampled from stainless steel plates spiked with different concentrations of drug solution. The protocol involves spiking plates with different concentrations of drug solution, sampling with swabs, extracting drug from swabs, measuring detector response of extracts, and calculating drug content and recovery percentage.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    68 views1 page

    Psychotropics India Limited: Plot No. - 46 & 49, Sector - 6A, IIE, SIDCUL, Haridwar (U.K.)

    Uploaded by

    markandey gupta
    The document describes a protocol for cleaning validation involving recovering drug from swabs sampled from stainless steel plates spiked with different concentrations of drug solution. The protocol involves spiking plates with different concentrations of drug solution, sampling with swabs, extracting drug from swabs, measuring detector response of extracts, and calculating drug content and recovery percentage.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 1

    Psychotropics India Limited

    Plot No. – 46 & 49, Sector -6A, IIE, SIDCUL, Haridwar (U.K.)

    Department: Quality Assurance Document No.: PIL/QA/CV/T/00


    Title: Protocol for Cleaning Validation Revision No.: 00
    Annex V: Recovery of drug from swabs sampled from spiked S.S. plates Effective Date: 10.05.2015
    Page No.: 1 of 1

    Recovery of drug from swabs sampled from spiked S.S. plates.

    API working standard No. : ____________

    Potency: _________

    Concentration of solution used for spiking 1 2 3


    the S.S.Plates
    Concentration of standard solution

    Mean Detector response

    Drug Swab No. 1 2 3 Mean RSD


    Content 
    per %
    swab
    Mean Detector Response
    Conc. 1 Content of Drug (mcg/ml)

    % Recovery

    Mean Detector Response


    Conc. 2 Content of Drug (mcg/ml)

    % Recovery

    Mean Detector Response


    Conc. 3 Content of Drug (mcg/ml)

    % Recovery

    Content of Drug in swab = Mean Detector response of extract solvent X Conc. of standard
    ____________________________________________________
    Mean Detector response of standard.

    Analyzed By Checked By
    Sign / Date Sign / Date

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