Chinese Professional Tenofovir Alafenamide Fumarate - USP 175865-59-5 Valganciclovir hydrochloride for Antiviral – Yibai
Chinese Professional Tenofovir Alafenamide Fumarate - USP 175865-59-5 Valganciclovir hydrochloride for Antiviral – Yibai Detail:
| 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 |
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Valganciclovir hydrochloride Cas: 175865-59-5 |
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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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