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    COA of Nystatin

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    arf
    This certificate of analysis is for a batch of nystatin produced by Shaanxi Pioneer Biotech Co., Ltd. The batch number is PB180710 with a manufacture date of July 10, 2018 and expiration date of July 9, 2020. Analysis shows the nystatin powder meets all specifications for appearance, potency, solubility, pH, loss on drying, sulphated ash, heavy metals and conforms to BP2010/USP 35 standards. The certificate recommends storing the nystatin in an airtight container protected from light with a shelf life of 2 years.

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    COA of Nystatin

    Uploaded by

    arf
    144 views1 page
    This certificate of analysis is for a batch of nystatin produced by Shaanxi Pioneer Biotech Co., Ltd. The batch number is PB180710 with a manufacture date of July 10, 2018 and expiration date of July 9, 2020. Analysis shows the nystatin powder meets all specifications for appearance, potency, solubility, pH, loss on drying, sulphated ash, heavy metals and conforms to BP2010/USP 35 standards. The certificate recommends storing the nystatin in an airtight container protected from light with a shelf life of 2 years.

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    This certificate of analysis is for a batch of nystatin produced by Shaanxi Pioneer Biotech Co., Ltd. The batch number is PB180710 with a manufacture date of July 10, 2018 and expiration date of July 9, 2020. Analysis shows the nystatin powder meets all specifications for appearance, potency, solubility, pH, loss on drying, sulphated ash, heavy metals and conforms to BP2010/USP 35 standards. The certificate recommends storing the nystatin in an airtight container protected from light with a shelf life of 2 years.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
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    144 views1 page

    COA of Nystatin

    Uploaded by

    arf
    This certificate of analysis is for a batch of nystatin produced by Shaanxi Pioneer Biotech Co., Ltd. The batch number is PB180710 with a manufacture date of July 10, 2018 and expiration date of July 9, 2020. Analysis shows the nystatin powder meets all specifications for appearance, potency, solubility, pH, loss on drying, sulphated ash, heavy metals and conforms to BP2010/USP 35 standards. The certificate recommends storing the nystatin in an airtight container protected from light with a shelf life of 2 years.

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    PIONEER 陕西帕尼尔生物科技有限公司

    BIOTECH
    Shaanxi Pioneer Biotech Co., Ltd
    Certificate of Analysis

    Product Name Nystatin Manufacture Date July. 10 ,2018


    Batch Number PB180710 Certificate Date July. 11 ,2018

    Batch Quantity 300kg Expiration Date July. 9 ,2020

    Analysis Specification Results

    Appearance Yellow to slightly brownish powder, hygroscopic. Complies


    Potency ≥4400 IU/mg 6200IU/mg
    Practically insoluble in water, freely soluble in dimethylformamide
    Solubility and in dimethyl sulphoxide,slightly soluble in methanol, practically Complies
    insoluble in alcohol.
    PH 6.0-8.0 7.1

    Loss on Drying ≤ 5.0% 2.9%

    Sulphated ash ≤3.5% 0.8%

    Heavy metal ≤ 20ppm <20ppm


    Conclusion Conform with BP2010/USP 35 Standard

    Storage Store in In an airtight container , protected from light.

    Shelf life 2 years when properly stored

    Add: No.2Daxing East Road, Xi’an , China Web：www.pioneerbiotech.com


    Tel：86-29-84385017(Fax) Email: sales5@pioneerbiotech.com

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