USP 175865-59-5 Valganciclovir hydrochloride maka mgbochi nje
| Ngwaahịaaha | Valganciclovir hydrochloride |
| Ụdị okwu | 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 Mba. | 175865-59-5 |
| Ọdịdị | Uzuzu crystalline ọcha ma ọ bụ na-acha ọcha |
| Usoro ihe omimi | C14H22N6O5.HCl |
| Ibu molekụla | 390.83 |
| Ojiji | Ọkwa ọgwụ ma ọ bụ ebumnuche nyocha |
| Nkwakọ ngwaahịa | Dị ka arịrịọ gị si dị |
| Nchekwa | Chekwaa n'ime akpa siri ike, nke na-enweghị ọkụ n'ebe dị mma |
| Valganciclovir hydrochloride ihe mejupụtara:175865-59-5 | ||
| Ihe | Ọkọlọtọ | Nsonaazụ |
| Ọdịdị | Uzuzu crystalline ọcha ma ọ bụ na-acha ọcha | ọcha ntụ ntụ |
| njirimara | Absorption infrared: dakọtara na ọkọlọtọ ntụakaAbsorption Ultraviolet: dakọtara na ọkọlọtọ ntụakaIhe ngwọta dị na mmiri (1 n'ime 20) na-emezu ihe achọrọ maka ule maka Chloride | Na-akwado Na-akwado
Na-akwado |
| Isopropyl mmanya | ≤1.0% | 0.13% |
| Mmiri | ≤8.0% | 4.5% |
| Ọla dị arọ | ≤20ppm | Na-akwado |
| Pd | ≤10ppm | 10pm |
| Ihe fọdụrụ na mgbanye | ≤0.1% | 0.02% |
| adịghị ọcha ndị emetụtara | Valganciclovir:Ganciclovir: ≤1.5%guanine: ≤1.5% Methoxymethylguanine: ≤0.3% Isovalganciclovir: ≤0.5% Monoacetoxyganciclovir: ≤0.15% Bis-valine Ista nke ganciclovir: ≤0.1% Ọnụnọ nke 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% Otu adịghị ọcha ọzọ achọpụtara: ≤0.1% Ngụkọta adịghị ọcha ndị ọzọ achọpụtara: ≤0.1% Ganciclovir mono-N-methyl valinate (Nnwale 2):≤0.3% Otu adịghị ọcha a na-amatabeghị (Nnwale 1 na 2): ≤0.1 % Ngụkọta adịghị ọcha amataghị (Nnwale 1 na 2): ≤0.25% Mkpokọta adịghị ọcha (Nnwale 1 na Nnwale 2): ≤3.0 | /0.02%0.01% 0.03% 0.02% ND 0.04% 0.01% 0.01% 0.004% ND ND ND ND Kachasị 0.04% 0.04%
0.02% Kachasị 0.02% 0.13% 0.78% |
| Diasteromer oke | 45:55 ruo 55:45 | 54:46 |
| Enantiomeric ịdị ọcha nke valganciclovir | ≥97.0% | 99.9% |
| HPLC nyocha | 97.0% ~ 102.0% | 98.8% |
| Mmechi: na-akwado USP40. | ||
Ozi ụlọ ọrụ
√ Ahụmahụ zuru oke nke oyi akwa na ụlọ ọrụ mmepụta ihe na ndị na-eso ụzọ teknụzụ nwere nkà; √ Quality bụ mgbe anyị n'elu echiche, siri ike QC usoro; √ 11 afọ nwere ahụmahụ mbupụ ahịa otu; √ ụlọ nyocha R&D nọọrọ onwe ya; √ Ụlọ ọrụ GMP abụọ bịanyere aka na ogologo oge; √ Akụ bara ụba nke ọtụtụ ụlọ ọrụ na-abaghị uru maka ọrụ ahaziri iche; √ Ndị otu na-arụ ọrụ nke ọma na ụzọ na-agbanwe agbanwe.
