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    Artemether IP

    Uploaded by

    Anjali Abhilashi

    Copyright:

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

    Artemether IP

    Uploaded by

    Anjali Abhilashi
    7 views2 pages

    Copyright

    © © All Rights Reserved

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    PDF, TXT or read online from Scribd

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    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    7 views2 pages

    Artemether IP

    Uploaded by

    Anjali Abhilashi

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Create life valuable………..

    CERTIFICATE OF ANALYSIS
    Product: Artemether IP
    Batch No. NA Customer NA
    Quantity 100.0 kg Mfg. Date NA
    CAS No. 71963-77-4 Analysis Date NA
    Molecular C16H26O5 Re-test Date NA
    Formula
    Molecular 298.37 g/mol Package As per customer requirement
    Weight

    S. Test Result Specification


    No.
    1.0 Description A white crystalline powder White crystals or a white
    crystalline powder.
    2.0 Solubility Practically insoluble in Practically insoluble in
    water,Very soluble in water,Very soluble in
    dichloromethane and dichloromethane and
    acetone,freely soluble in acetone,freely soluble in
    ethylacetate & dehydrated ethylacetate & dehydrated
    ethanol . ethanol .
    3.0 Identification
    By IR Complies As per International
    Pharmacopeia.
    By HPLC Complies In the test for purity by HPLC,
    the retention time of the
    principal peak obtained in the
    chromatogram of sample
    should correspond to that
    obtained in the chromatogram
    of standard.
    4.0 Melting Point Between 88 to 89°C Between 86 to 90°C
    5.0 Specific Optical Rotation +170.3° Between +166° to +173°
    (1% w/w solution in
    dehydrated Alcohol)
    6.0 Sulphated Ash 0.7 mg/g NMT 1.0mg/g
    7.0 Loss of Drying (%, w/w) 0.3% Not 0.5%

    +91 9822319778
    [email protected] A-104, Nea CHS, S.No.41/42,
    +91 8007935656
    Behind TUVNORD Pvt. Ltd.,
    Baner Annexe -411021
    Create life valuable………..

    8.0 Related substance (By


    HPLC)
    Any Single Impurity 0.21% NMT 0.5%
    Any other Impurity 0.07% NMT 0.25%
    Total impurity 0.35% NMT 1.0%
    Purity by HPLC (% w/w) 99.35% Not less than 99.0%
    Any other individual 0.20 NMT0.5%
    impurity 0.45% NMT 1.0%
    Total impurity
    9.0 Assay by HPLC On dried 99.5% NMT 97.0% to 102.0%
    basis

    Result: The product CONFIRMS to the above specification.

    Complied by : Approved by :

    +91 9822319778
    [email protected] A-104, Nea CHS, S.No.41/42,
    +91 8007935656
    Behind TUVNORD Pvt. Ltd.,
    Baner Annexe -411021

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