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    QC 351

    Uploaded by

    Rana Tayyab
    1) The certificate of analysis is for Diclofenac Potassium BP 2020 batch number DFK/10070088 manufactured in July 2020. 2) Tests results show the batch meets British Pharmacopoeia 2020 specifications for appearance, solubility, identification, appearance of solution, related substances by HPLC, loss on drying, assay by potentiometry, and pH. 3) The quality control manager approved the batch as meeting all BP 2020 specifications.

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    QC 351

    Uploaded by

    Rana Tayyab
    60 views1 page
    1) The certificate of analysis is for Diclofenac Potassium BP 2020 batch number DFK/10070088 manufactured in July 2020. 2) Tests results show the batch meets British Pharmacopoeia 2020 specifications for appearance, solubility, identification, appearance of solution, related substances by HPLC, loss on drying, assay by potentiometry, and pH. 3) The quality control manager approved the batch as meeting all BP 2020 specifications.

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    QC_351(1)

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    1) The certificate of analysis is for Diclofenac Potassium BP 2020 batch number DFK/10070088 manufactured in July 2020. 2) Tests results show the batch meets British Pharmacopoeia 2020 specifications for appearance, solubility, identification, appearance of solution, related substances by HPLC, loss on drying, assay by potentiometry, and pH. 3) The quality control manager approved the batch as meeting all BP 2020 specifications.

    Copyright:

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

    QC 351

    Uploaded by

    Rana Tayyab
    1) The certificate of analysis is for Diclofenac Potassium BP 2020 batch number DFK/10070088 manufactured in July 2020. 2) Tests results show the batch meets British Pharmacopoeia 2020 specifications for appearance, solubility, identification, appearance of solution, related substances by HPLC, loss on drying, assay by potentiometry, and pH. 3) The quality control manager approved the batch as meeting all BP 2020 specifications.

    Copyright:

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

    CORPORATE OFFICE : Ptot No.

    1o9-0, Mahendra lndustrial Estate,


    =D
    l= Ground Floor. Road No-29, Sion (East). Mumbai - 400 022. (lndia)

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    = Menuracrurs. or : Burf'D,ues & chemrcars
    H,!f;illi.*i: J#.3.11#l ?!;;Tliili,;;3H.1,,,f;5i.31:'
    QUALITY CONTROL
    CERTIFICATE OF ANALYSIS

    PRODUCT NAME : DICLOFENAC POTASSIUM BP 2020


    BATCH NO. : DFK/'10070088
    MFG. DATE July'2020 A.R.NO, : FP12011644

    EXP. DATE : June' 2025 RELEASE DATE 2910812020


    sR. TESTS SPECIFICATION RESULTS
    NO.
    1 Appearance White or slightly yellowish, slightly hygroscopic, White crystalline powder, slightly
    crystalline powder, hygroscopic,

    2 Solubility Sparinqly soluble in water, freely soluble in methanol, Sparingly soluble in water, freely
    soluble in Ethanol (96%), slightly soluble in acelone. soluble in methanol, soluble in
    Ethanol (96%), slightly soluble in
    acetone.
    3 ldentilication
    A. L R Spectrum The lnfrared absorption speclrum of sample is Concordant with lR absorplion
    concordant with lnfrared absorption spectrum of spectrum of Diclofenac potassium
    Diclofenac potassium WS. ws.
    B. TLC The principal spot obtained in test solulion is similar The principal spot obtained in test
    in position and size to the principal spot obtained with solulion is similar to the principal spot
    reference solution (a). obtained with reference solution (a).

    C. As per IH/BP/EP A blue color develops and a precipitate is form A blue color develops and a
    precipitate is form.

    D. Reaction (b) of potassium A yellow or orange yellow precipitate is formed Gives reaction for potassium
    4 Appearance of solution The solution is clear and absorbance measured at Solution is clear and absorbance is
    440 nm is not greater than 0.05 0.0154
    5 Related substances by HPLC
    . lmpurity A Not more than 0.15 % Not detected.
    r lmpurity F Not more than 0.15 % Not detected.
    . Unspecifiedlmpurities Not more than 0.'10 % Not detected
    . Total impurities Not more than 0.4 % Not detected
    6 Loss on drying Maximum 0.9 %, determined on '1.0 g by drying in an o.28./.
    uC
    oven at 105 for 3 hrs.
    7 Assay by potentiometrically Not less than 99 % and not more than 10'l % of
    C Hro ClzKNOz, calculated with reference to lhe 99.85 %
    dried substance
    8 pH. Between 6.5 and 8.5, determined on a 1% Wv 7.25
    solulion.
    Opinion The above material passes as per BP 2020 Specification

    Analyzed By

    QC Officer
    '@
    .I\rgu-
    Checked By

    QC Asst. Manager
    I
    Approved By

    OC Manager
    89
    Va;ti^.l".,+, ran4-1 I

    Date r-r\u[\Tar.r Date Date


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