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    Certificate of Analysis: Liaoning Oxiranphex Inc

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    Dilawar Bakht
    This document is a certificate of analysis for a shipment of polyethylene glycol (PEG) 6000. It summarizes the results of testing conducted on a batch of 80 cartons containing 20 kg of PEG 6000 each. All test results, including for appearance, identification, solution properties, average molecular weight, viscosity, freezing point, hydroxyl value, and presence of impurities, met the standards according to current European Pharmacopeia and United States Pharmacopeia specifications. The conclusion is that the PEG 6000 batch meets all requirements.

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    Certificate of Analysis: Liaoning Oxiranphex Inc

    Uploaded by

    Dilawar Bakht
    409 views1 page
    This document is a certificate of analysis for a shipment of polyethylene glycol (PEG) 6000. It summarizes the results of testing conducted on a batch of 80 cartons containing 20 kg of PEG 6000 each. All test results, including for appearance, identification, solution properties, average molecular weight, viscosity, freezing point, hydroxyl value, and presence of impurities, met the standards according to current European Pharmacopeia and United States Pharmacopeia specifications. The conclusion is that the PEG 6000 batch meets all requirements.

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    Original Title

    Peg-6000 Ep-usp Coa (1)

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    This document is a certificate of analysis for a shipment of polyethylene glycol (PEG) 6000. It summarizes the results of testing conducted on a batch of 80 cartons containing 20 kg of PEG 6000 each. All test results, including for appearance, identification, solution properties, average molecular weight, viscosity, freezing point, hydroxyl value, and presence of impurities, met the standards according to current European Pharmacopeia and United States Pharmacopeia specifications. The conclusion is that the PEG 6000 batch meets all requirements.

    Copyright:

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

    Certificate of Analysis: Liaoning Oxiranphex Inc

    Uploaded by

    Dilawar Bakht
    This document is a certificate of analysis for a shipment of polyethylene glycol (PEG) 6000. It summarizes the results of testing conducted on a batch of 80 cartons containing 20 kg of PEG 6000 each. All test results, including for appearance, identification, solution properties, average molecular weight, viscosity, freezing point, hydroxyl value, and presence of impurities, met the standards according to current European Pharmacopeia and United States Pharmacopeia specifications. The conclusion is that the PEG 6000 batch meets all requirements.

    Copyright:

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

    辽宁奥克医药辅料股份有限公司

    LIAONING OXIRANPHEX INC.


    地址（Add.）：辽宁省辽阳市宏伟区万和二路 58 号 电话（Tel.）：0419-5169238
    网址（Web.）：www.oxiranphex.com 传真（Fax.）：0419-5162958

    CERTIFICATE OF ANALYSIS
    Product： （PEG）6000 Bath NO.： 20191029156
    Package： 20kg/Cartons Quantity： 80Cartons*20kg
    Analysis date： 2019.11.01 Report date： 2019.11.02
    Manufacturing date： 2019.10.29 Valid date： 2021.11.01
    Technical specification： Current EP/USP

    Analytical Result
    Test items Standard Result
    methods found
    White or almost white solid Flakes
    Appearance (25℃) Current EP Fine Powder Qualified
    or Powder
    Current EP A Conforms Qualified
    Identification Current EP B Conforms Qualified
    Current EP C Conforms Qualified
    Appearance of solution Current EP Meet requirements Pass Qualified
    Completeness and Color of
    Current USP Meet requirements Pass Qualified
    Solution
    Acidity or alkalinity Current EP Meet requirements Conforms Qualified
    pH ( 5% in water) Current USP 4.5～7.5 6.7 Qualified
    Average Molecular Weight Current USP 5400～6600 6280 Qualified
    Viscosity(98.9℃，cst) Current USP 250～390 343 Qualified
    Viscosity(20℃，mPa·s) Current EP 200～270 242 Qualified
    Freezing point（℃） Current EP 55～61 58 Qualified
    Hydroxyl value Current EP 16～22 20 Qualified
    Reducing substances Current EP Meet requirements Conforms Qualified
    Formaldehyde（ppm) Current EP ≤15 Conforms Qualified
    Ethylene oxide(ppm） Current EP ≤1 ND Qualified
    Dioxan(ppm） Current EP ≤10 ND Qualified
    Free Ethylene Oxide(μg/g) Current USP ≤10 0 Qualified
    1,4-Dioxane(μg/g） Current USP ≤10 0 Qualified
    Water (%) Current EP ≤1.0 0.03 Qualified
    Sulfated ash(%) Current EP ≤0.2 0 Qualified
    Residue on Ignition（%) Current USP ≤0.1 0.07 Qualified
    Heavy Metals (ppm) Current USP ≤5 Pass Qualified

    Conclusion According to Current EP、Current USP standard,the results meet the requirements.

    QC Supervisor: Recheck: Analyst:

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