USP 175865-59-5 Valganciclovir hydrochloride rau Antiviral
| Khoomnpe | 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 Nr. | 175865-59-5 |
| Qhov tshwm sim | Dawb los yog tawm-dawb crystalline hmoov |
| Molecular Formula | C14H22N6O5.HCl |
| Molecular Luj | 390.83 ib |
| Kev siv | Pharmaceutical Qib lossis Kev Tshawb Fawb Lub Hom Phiaj |
| Ntim | Raws li koj qhov kev thov |
| Cia | Khaws nyob rau hauv nruj, lub teeb-resistant ntim nyob rau hauv ib qhov chaw txias |
| Valganciclovir hydrochloride Cas:175865-59-5 | ||
| Cov khoom | Txuj | Cov txiaj ntsig |
| Qhov tshwm sim | Dawb los yog tawm-dawb crystalline hmoov | hmoov dawb |
| Kev txheeb xyuas | Infrared Absorption: Ua raws li tus qauv sivUltraviolet Absorption: Ua raws li tus qauv sivIb qho kev daws teeb meem hauv dej (1 ntawm 20) ua tau raws li qhov yuav tsum tau ua ntawm kev ntsuam xyuas rau Chloride | Ua raws Ua raws
Ua raws |
| Isopropyl cawv | ≤ 1.0% | 0.13% |
| Dej | ≤8.0% | 4.5% |
| Cov hlau hnyav | ≤ 20ppm | Ua raws |
| Pd | ≤10ppm | 10 ppm |
| Cov seem ntawm ignition | ≤0.1% | 0.02% |
| Hais txog impurities | Valganciclovir: /Ganciclovir: ≤1.5%Guanine: ≤1.5% Methoxymethylguanine: ≤0.3% Isovalganciclovir: ≤0.5% Monoacetoxyganciclovir: ≤0.15% Bis-valine easter ntawm ganciclovir: ≤0.1% Homologue ntawm valganciclovir: ≤0.25% Qhov siab H: ≤0.1% Qhov siab: ≤0.1% Ganciclovir monopropionate: ≤0.15% Valganciclovir dimer (stereoisomer A): ≤0.1% Valganciclovir dimer (stereoisomer B): ≤0.1% Valganciclovir dimer (stereoisomer C): ≤0.1% Ib leeg lwm yam impurity: ≤0.1% Tag nrho lwm yam impurity: ≤0.1% Ganciclovir mono-N-methyl valinate (Test 2): ≤0.3% Ib qho tsis paub meej impurity (Test 1 thiab 2): ≤0.1% Tag nrho cov tsis paub meej impurity (Test 1 thiab 2): ≤0.25% Tag nrho cov impurities (Test 1 thiab 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 piv | 45:55 – 55:45 dr hab | 54:46 ib |
| Enantiomeric purity ntawm valganciclovir | ≥97.0% | 99.9% |
| HPLC kev xeem | 97.0% ~ 102.0%. | 98.8% |
| Xaus: ua raws li USP40. | ||
Cov ntaub ntawv tuam txhab
√ Kev tswj cov txheej txheem tag nrho hauv lub Hoobkas thiab cov kws tshaj lij cov neeg ua haujlwm; √ Zoo yog ib txwm peb xav txog sab saum toj, nruj QC system; √ 11 xyoo dhau los ntawm pab pawg muag khoom; √ Kev ywj pheej R & D lab; √ Ob qhov kev kos npe mus sij hawm ntev GMP kev cob qhia; √ Cov peev txheej nplua nuj ntawm ntau lub chaw ua haujlwm tsis ua haujlwm rau qhov project customized; √ Pab neeg ua haujlwm siab ua haujlwm nrog txoj hauv kev zoo ib yam.
