USP 175865-59-5 Valganciclovir hydrochloride kanggo Antiviral
produkjeneng | Valgansiklovir hidroklorida |
sinonim | L-Valine,2-[(2-aMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Metoksi]-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 |
Nomer CAS | 175865-59-5 |
Penampilan | Wêdakakêna kristal putih utawa putih-putih |
Formula Molekul | C14H22N6O5.HCl |
Bobot Molekul | 390.83 |
Panggunaan | Pharmaceutical Grade utawa tujuan Riset |
Packing | Kaya sing dikarepake |
Lumbung | Simpen ing wadhah sing kenceng lan tahan cahya ing papan sing adhem |
Valganciclovir hydrochloride Cas:175865-59-5 | ||
barang | Standar | Asil |
Penampilan | Wêdakakêna kristal putih utawa putih-putih | bubuk putih |
Identifikasi | Penyerapan inframerah: Cocog karo standar referensiPenyerapan Ultraviolet: Cocog karo standar referensiSolusi ing banyu (1 ing 20) nyukupi syarat tes kanggo Klorida | tundhuk tundhuk
tundhuk |
Isopropil alkohol | ≤1,0% | 0,13% |
banyu | ≤8,0% | 4,5% |
Logam abot | ≤20ppm | tundhuk |
Pd | ≤10ppm | <10 ppm |
Sisa ing ignition | ≤0,1% | 0,02% |
impurities related | Valgansiklovir: /Ganciclovir: ≤1,5%Guanin: ≤1,5% Methoxymethylguanine: ≤0,3% Isovalganciclovir: ≤0,5% Monoacetoxyganciclovir: ≤0,15% Paskah bis-valine gansiklovir: ≤0,1% Homolog saka 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% Tunggal liyane sing diidentifikasi najis: ≤0.1% Total najis liyane sing diidentifikasi: ≤0,1% Ganciclovir mono-N-methyl valinate (Tes 2): ≤0,3% Najis tunggal sing ora dingerteni (Uji 1 lan 2): ≤0,1 % Total najis sing ora dingerteni (Tes 1 lan 2): ≤0,25% Total impurities (Test 1 lan 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 Maks 0,04% 0,04%
0,02% Maks 0,02% 0,13% 0,78% |
Diastereomer rasio | 45:55 kanggo 55:45 | 54:46 |
Kemurnian enantiomer saka valganciclovir | ≥97,0% | 99,9% |
Pengujian HPLC | 97,0%~102,0% | 98,8% |
Kesimpulan: tundhuk karo USP40. |