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    Deflizox 6

    Uploaded by

    Ashish Sharma
    This certificate of analysis is for Deflizox 6 mg tablets, batch number ATDZT3001L, manufactured in January 2023. Test results show the tablets comply with specifications for appearance, identification, average weight, uniformity of weight, disintegration time, uniformity of content, and assay. The results confirm the batch meets quality standards and it was approved for release in February 2023. Store below 25°C protected from light and moisture.

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

    Deflizox 6

    Uploaded by

    Ashish Sharma
    54 views1 page
    This certificate of analysis is for Deflizox 6 mg tablets, batch number ATDZT3001L, manufactured in January 2023. Test results show the tablets comply with specifications for appearance, identification, average weight, uniformity of weight, disintegration time, uniformity of content, and assay. The results confirm the batch meets quality standards and it was approved for release in February 2023. Store below 25°C protected from light and moisture.

    Original Title

    DEFLIZOX 6

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    This certificate of analysis is for Deflizox 6 mg tablets, batch number ATDZT3001L, manufactured in January 2023. Test results show the tablets comply with specifications for appearance, identification, average weight, uniformity of weight, disintegration time, uniformity of content, and assay. The results confirm the batch meets quality standards and it was approved for release in February 2023. Store below 25°C protected from light and moisture.

    Copyright:

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

    Deflizox 6

    Uploaded by

    Ashish Sharma
    This certificate of analysis is for Deflizox 6 mg tablets, batch number ATDZT3001L, manufactured in January 2023. Test results show the tablets comply with specifications for appearance, identification, average weight, uniformity of weight, disintegration time, uniformity of content, and assay. The results confirm the batch meets quality standards and it was approved for release in February 2023. Store below 25°C protected from light and moisture.

    Copyright:

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

    ASSOCIATED BIOTECH

    Quality Control Department


    Certificate of Analvsis
    Product Nane : DEFLIZOX 6
    Generic Name : Deflazacort Tablets 6 mg
    Batch Number : ATDZT3001L | ,q,.n No. : FpG0223003
    Batch Size : 1.00 Lac
    I Mfg. Date : JAN.2023
    I

    Qty.Sampled : 60 Tabs. Exp. Date z DEC.2024


    Receipt Date z 01.02.2023 Released Date z 02.02.2023

    Sr. No. Test Specification Result


    I Description Off white colour, round shape, Off white coloured, round
    flat, uncoated tablets having break shaped, flat, uncoated tablets
    line on one side & other sid! plain. having break line on one side

    o v
    I
    & other side plain.
    2. Identification @y HPLC) In the assay, the principal peak in
    the chromato$am obtained with
    the test solution corresponds to the
    peak in the chromatogram
    obtained with the standard
    solution. Positive
    3. Average weight i00.0 mg + 5.0% 100.3 mg

    4. Uniformity of weight +75% of the average weight -1.07%+1.32%

    5. Disintegration NMT 15 minutes 25 seconds

    6. Uniformity of contsnt (By HPLC) Befween 85.0% and 97A%to


    \- 1 | 5.0% 106.5%

    n
    Assay @y HPLC)
    Each uncoated tablet contains:
    Deflazacort 6 me 5.40 mg to 6.60 mg 5.92 mg

    Rem arks: The above sample comdties/dqss-not comply wrtn prescribed standird
    with prescn of quality
    ualitv as per
    ner In house
    speoification.

    : Store below 25oC. Protected from I t & moisture


    Analysed By Checked By Approved By
    Signature
    4P- (lh flA ------:
    Date
    el-{ o+--lr--}
    "2
    t-?lL)
    m] o\-t e I

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