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    Weizo DSR

    Uploaded by

    Ashish Sharma
    This certificate of analysis summarizes quality control testing of a batch of WEIZO-DSR peridone prolonged release capsules. Key results: 1) All tested parameters including description, identification, average filled weight, uniformity, gastric resistance, dissolution, related substances, and assay were within specified limits. 2) The batch passed all tests and complies with quality standards. 3) The capsules contain the specified amounts of pantoprazole sodium and domperidone and should be stored below 25°C, protected from light and moisture.

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    © All Rights Reserved
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    Weizo DSR

    Uploaded by

    Ashish Sharma
    210 views1 page
    This certificate of analysis summarizes quality control testing of a batch of WEIZO-DSR peridone prolonged release capsules. Key results: 1) All tested parameters including description, identification, average filled weight, uniformity, gastric resistance, dissolution, related substances, and assay were within specified limits. 2) The batch passed all tests and complies with quality standards. 3) The capsules contain the specified amounts of pantoprazole sodium and domperidone and should be stored below 25°C, protected from light and moisture.

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    WEIZO-DSR

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    This certificate of analysis summarizes quality control testing of a batch of WEIZO-DSR peridone prolonged release capsules. Key results: 1) All tested parameters including description, identification, average filled weight, uniformity, gastric resistance, dissolution, related substances, and assay were within specified limits. 2) The batch passed all tests and complies with quality standards. 3) The capsules contain the specified amounts of pantoprazole sodium and domperidone and should be stored 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
    210 views1 page

    Weizo DSR

    Uploaded by

    Ashish Sharma
    This certificate of analysis summarizes quality control testing of a batch of WEIZO-DSR peridone prolonged release capsules. Key results: 1) All tested parameters including description, identification, average filled weight, uniformity, gastric resistance, dissolution, related substances, and assay were within specified limits. 2) The batch passed all tests and complies with quality standards. 3) The capsules contain the specified amounts of pantoprazole sodium and domperidone and should be stored below 25°C, protected from light and moisture.

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    ASSOCIATED BIOTECH

    Quality Control Department


    Certificate of Analysis
    Product Name : WEIZO-DSR
    peridone prolonged Release Capsules Ip
    Batch i\umber : ACPD3002C A.R. No. : FPG0123073
    Batch Size : 1.00 Lac Mfg. Date : JAN.2023
    Qty. Sampled : 60 Caps. Exp. Date : D8C.2024
    Receipt Date z 11.01.2023 Date
    Released : 25.01.2023

    Sr. No. Test Specification Result


    I Descripfion Multi colour spherical pellets filled Multi coloured spherical
    in light green colour cap & body of pellets filled in light green
    hard gelatin capsule. coloured cap & body of hard
    gelatin capsules.
    2. Identification @y HPLC) In the assay, the retention time of
    principal peak in chromatogram of
    sample preparation corresponds to
    that of standard preparation.
    v' a
    J. Average filled rveight 290.0 mg* 5.0%
    Positive
    289.9 mg
    +,
    A
    Uniformity of filled weight t 10.0% of average filled weight -353%to +5.02%
    5. Gastric resistance @y HpLC) NMT 10.0% dissolved in 0.1 M
    ( Pantoprazole) HCI -9.9%to9.lYo
    6. Dissolution (By IIPLC)
    Pantoprazole D. NLT 70.0% in phosphare buffer 94.4%to 108.2%o

    Domperidone (SR) l'tHr. Between 15.0 %oto40.0oh 249% to 34.1o/o


    4'r'Hr. Befween 30.0% to 65.0%o 40.1%to 58.2%
    8th FIr. Between 55.O%to 85.0% 66.8% to76.3%
    l2t' Hr.Not less than 7 0.0%o 84.7%to 94.8%o
    7. Related Substances (By IIpLC)
    For Pantoprazole
    Any Secondary peak NMT 0.2% 0.03%
    Impurity A NMT 0.5% Not detected
    A- Impurity B NMT 0.3% Not detected
    Impurity D&F NMT 0.75% Not detected
    Sum ofall the secondary peak NMT 1.5% 0.06%
    For Domperidone
    Any Secontlary peak NMT 0.5% 0.40%
    Sum qfall the secondary peak NMT 2.0% 0.85%
    8. Assay (By IIPLC)
    Each hard gelatin capsule contains:
    Pantoprazole sodium Ip
    (as sesquihydrate)
    eq. to Pantoprazole 40 mg 36.0 mg to 44.0 mg 40.02 mg
    (as enteric coated pellets)
    Domperidone IP 30 nie 27.0 mgto 33.0 mg 30.39 mg
    (as sustained release pellets)
    ;
    (emarl{s Ihe above sample
    ple comolfes/ ply with
    omDlv w prescribed standard of qra@
    to Store bel ow2 from light & moisture.
    Analysed Bv Chgcked By i A-peroved By
    Drgnalure

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