USP 175865-59-5 Valganciclovir hydrochloride għal Antivirali
Prodottisem | Valganciclovir hydrochloride |
Sinonimi | 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 Nru. | 175865-59-5 |
Dehra | Trab kristallin abjad jew offwajt |
Formula Molekulari | C14H22N6O5.HCl |
Piż Molekulari | 390.83 |
Użu | Grad Farmaċewtiku jew għan ta' Riċerka |
Ippakkjar | Skont it-talba tiegħek |
Ħażna | Ippreserva f'kontenituri ssikkati u reżistenti għad-dawl f'post frisk |
Valganciclovir hydrochloride Cas:175865-59-5 | ||
Oġġetti | Standard | Riżultati |
Dehra | Trab kristallin abjad jew offwajt | trab abjad |
Identifikazzjoni | Assorbiment infra-aħmar: Jikkorrispondi għal dak ta 'standard ta' referenzaAssorbiment ultravjola: Jikkorrispondi għal dak ta 'standard ta' referenzaSoluzzjoni fl-ilma (1 f'20) tissodisfa r-rekwiżiti tat-testijiet għall-Klorur | Jikkonforma Jikkonforma
Jikkonforma |
Alkoħol isopropiliku | ≤1.0% | 0.13% |
Ilma | ≤8.0% | 4.5% |
Metalli tqal | ≤20ppm | Jikkonforma |
Pd | ≤10ppm | <10ppm |
Residwu fuq it-tqabbid | ≤0.1% | 0.02% |
Impuritajiet relatati | Valganciclovir: /Ganciclovir: ≤1.5%Guanine: ≤1.5% Methoxymethylguanine: ≤0.3% Isovalganciclovir: ≤0.5% Monoacetoxyganciclovir: ≤0.15% Bis-valine easter ta 'ganciclovir: ≤0.1% Omologu ta' 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% Impurità identifikata oħra waħda: ≤0.1% Total impurità oħra identifikata: ≤0.1% Ganciclovir mono-N-methyl valinate (Test 2):≤0.3% Impurità waħda mhux identifikata (Test 1 u 2): ≤0.1 % Impurità totali mhux identifikata (Test 1 u 2): ≤0.25% Impuritajiet totali (Test 1 u 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% |
Diastereomeru proporzjon | 45:55 sa 55:45 | 54:46 |
Purità enantiomerika ta 'valganciclovir | ≥97.0% | 99.9% |
Assaġġ HPLC | 97.0%~102.0% | 98.8% |
Konklużjoni: jikkonforma ma 'USP40. |