Function: | Antiviral |
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Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | Not Volatile |
Standard: | USP |
Samples: |
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Test | Method | Limits | Results |
Description | White crystalline powder | White to off-white powder | White powder |
Identification | A:Infrared Absorption<197k> | Spectrum similar to reference standard | Complies |
B:Ultraviolet Absorption<197U> | Spectrum similar to reference standard | Complies | |
C:Chloride<191> | Conform to the requirements | Complies | |
Water | USP41 Method I<921> | Not more than 8.0% | 4.7% |
Isopropyl alcohol | USP41 Method I | Not more than 1.0% | 0.4% |
Residue on ignition | USP41 <281> | Not more than 0.10% | 0.06% |
Related impurities(HPLC) | Valganciclovir | - | - |
Ganciclovir | Not more than 1.5% | 0.29% | |
Methoxymethylguanine | Not more than 0.3% | Complies | |
Guanine | Not more than 0.25% | 0.09% | |
Isovalganciclovir | Not more than 0.5% | Complies | |
Monoacetoxy ganciclovir | Not more than 0.15% | 0.02% | |
Bis-valine easter of ganciclvoir | Not more than 0.1% | Complies | |
Homologue of valganciclovir | Not more than 0.25% | Complies | |
H | Not more than 0.1% | Complies | |
I | Not more than 0.1% | Complies | |
Ganciclovir monopropionate | Not more than 0.15% | 0.09% | |
Valganciclovir dimer (Stereoisomer A) |
Not more than 0.1% | Complies | |
Valganciclovir dimer (Stereoisomer B) |
Not more than 0.1% | Complies | |
Valganciclovir dimer (Stereoisomer C) |
Not more than 0.1% | Complies | |
Ganciclovir mono-N-methylvalinate | Not more than 0.3% | Complies | |
Other identified impurity | Not more than 0.1% | Complies | |
Unidentified impurity | Not more than 0.1% | Complies | |
Total of all impurities | Not more than 3.0% | 1.3% | |
Diastereomer ratio (R and S esters of L-valline) |
HPLC Chromatography<621> | 45:55 to 55:45 | 53:47 |
Residual solvents | GC Chromatography<621> | Isopropanol≤5000ppm | 2480ppm |
Methanol≤3000ppm | 1390ppm | ||
Toluene≤890ppm | 0ppm | ||
Methylene chloride≤600ppm | 0ppm | ||
Acetone≤5000ppm | 0ppm | ||
Enantiomeric Purity of Valganciclovir | HPLC Chromatography<621> | Not less than 97.0% | 98.0% |
Assay | HPLC Chromatography<621> | Not less than 97.0% and not more than 102.0% of C14H22N6O5·HCL,calculated on the anhyydrous and solvent-free basis. | 99.6% |
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