USP 175865-59-5 Valganciclovir hydrochloride pikeun Antiviral
| produkngaran | Valganciclovir hydrochloride |
| sinonim | 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 |
| Penampilan | Bubuk kristalin bodas atanapi pareum-bodas |
| Formula Molekul | C14H22N6O5.HCl |
| Beurat Molekul | 390.83 |
| Pamakéan | Kelas Farmasi atanapi Tujuan Panaliti |
| Bungkusan | Salaku per pamundut anjeun |
| Panyimpenan | Simpen dina wadah anu kedap, tahan cahaya di tempat anu tiis |
| Valganciclovir hydrochloride Cas:175865-59-5 | ||
| Barang | Standar | Hasilna |
| Penampilan | Bubuk kristalin bodas atanapi pareum-bodas | bubuk bodas |
| Idéntifikasi | Nyerep Infrabeureum: Cocog sareng standar rujukanNyerep Ultraviolet: Cocog sareng standar rujukanSolusi dina cai (1 dina 20) nyumponan sarat tés pikeun Klorida | matuh matuh
matuh |
| Isopropil alkohol | ≤1,0% | 0,13% |
| Cai | ≤8,0% | 4,5% |
| logam beurat | ≤20ppm | matuh |
| Pd | ≤10ppm | <10 ppm |
| Sesana dina ignition | ≤0,1% | 0,02% |
| Kotoran patali | Valganciclovir: /Ganciclovir: ≤1,5%Guanina: ≤1,5% Methoxymethylguanine: ≤0.3% Isovalganciclovir: ≤0,5% Monoacetoxyganciclovir: ≤0,15% Paskah bis-valina ganciclovir: ≤0,1% Homolog 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 najis anu diidentifikasi sanés: ≤0.1% Total najis séjén dicirikeun: ≤0.1% Ganciclovir mono-N-métil valinate (Tés 2): ≤0,3% Najis anu teu dipikanyaho tunggal (Test 1 sareng 2): ≤0,1% Total najis unidentified (Test 1 jeung 2): ≤0,25% Total pangotor (Test 1 jeung 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 babandingan | 45:55 ka 55:45 | 54:46 |
| Purity enantiomeric of valganciclovir | ≥97,0% | 99,9% |
| Uji HPLC | 97,0%～102,0% | 98,8% |
| Kacindekan: sasuai jeung USP40. | ||
Émbaran parusahaan
√ Pangalaman pinuh lapisan manajemén di pabrik sareng pengikut teknisi terampil; √ Kualitas salawasna tinimbangan luhur urang, Sistim QC ketat; √ 11 taun ngalaman exporting tim jualan; √ lab R&D mandiri; √ Dua bengkel GMP jangka panjang anu ditandatanganan; √ Sumberdaya anu beunghar ku seueur pabrik dianggurkeun pikeun proyék khusus; √ Tim kerja Efisiensi Tinggi kalayan jalur anu konsisten.
