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USP 175865-59-5 Valganciclovir hydrochloride for Antiviral

Short Description:


  • Purity: ≧97%, White or off-white powder
  • Quality Standard: USP40 or as required
  • Certificate: COA, MOA, MSDS, etc
  • Capacity: 50Kg/Month
  • Shelf Life: 2 Years
  • Application: A medication used to treat cytomegalovirus retinitis
  • Team Advantage: Experienced export sales team with professional training in factory
  • Product Detail

    FAQ

    Product Tags

    Product name Valganciclovir hydrochloride
    Synonyms L-Valine,2-[(2-aMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]-3-hydroxypropylester,hydrochloride(1:1);2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]-3-hydroxypropyl(2S)-2-amino-3-methylbutanoatehydChemicalbookrochloridehydrate;L-Valine,2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropylester,monohydrochloridehydrate
    CAS No. 175865-59-5
    Appearance White or off-white crystalline powder
    Molecular Formula C14H22N6O5.HCl
    Molecular Weight 390.83
    Usage Pharmaceutical Grade or Research purpose
    Packing As per your request
    Storage Preserve in tight,light-resistant containers in a cool place

     

    Valganciclovir hydrochloride Cas: 175865-59-5

    Items

    Standard

    Results

    Appearance White or off-white crystalline powder white powder
    Identification Infrared Absorption:Corresponds to that of reference standardUltraviolet Absorption:Corresponds to that of reference standardA solution in water (1 in 20) meets the requirements of the tests for Chloride Complies Complies

     

    Complies

    Isopropyl alcohol ≤1.0% 0.13%
    Water ≤8.0% 4.5%
    Heavy metals ≤20ppm Complies
    Pd ≤10ppm <10ppm
    Residue on ignition ≤0.1% 0.02%
    Related impurities Valganciclovir: /Ganciclovir: ≤1.5%Guanine: ≤1.5%

    Methoxymethylguanine: ≤0.3%

    Isovalganciclovir: ≤0.5%

    Monoacetoxyganciclovir:  ≤0.15%

    Bis-valine easter of ganciclovir: ≤0.1%

    Homologue of valganciclovir: ≤0.25%

    Imp H:  ≤0.1%

    Imp I: ≤0.1%

    Ganciclovir monopropionate: ≤0.15%

    Valganciclovir dimer (stereoisomer A): ≤0.1%

    Valganciclovir dimer (stereoisomer B): ≤0.1%

    Valganciclovir dimer (stereoisomer C): ≤0.1%

    Single other identified impurity: ≤0.1%

    Total other identified impurity: ≤0.1%

    Ganciclovir mono-N-methyl valinate (Test 2):≤0.3%

    Single unidentified impurity (Test 1 and 2): ≤0.1 %

    Total unidentified impurity (Test 1 and 2): ≤0.25%

    Total impurities (Test 1 and Test 2): ≤3.0

    /0.02%0.01%

    0.03%

    0.02%

    ND

    0.04%

    0.01%

    0.01%

    0.004%

    ND

    ND

    ND

    ND

    Max 0.04%

    0.04%

     

    0.02%

    Max 0.02%

    0.13%

    0.78%

    Diastereomer ratio 45:55 to 55:45 54:46
    Enantiomeric purity of valganciclovir ≥97.0% 99.9%
    HPLC assay 97.0%~102.0%  98.8%
    Conclusion: complies with USP40.

    Company Information

    √ Management layer’s full experience in factory and skilled technicians followers;
    √ Quality is always our top consideration, Strict QC system;
    √ 11 years experienced exporting sales team;
    √ Independent R&D lab;
    √ Two signed long term GMP workshops;
    √ Rich resources of plenty idle factories for customized project;
    √ High Efficiency working team with consistent path.
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