Vasega Fa'afoma'i 209216-23-9 Entecavir Monohydrate Mo Togafitiga ole Hepatitis B.
Oloaigoa | Entecavir monohydrate |
Synonyms | 2-Amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one monohydrate |
CAS Nu. | 209216-23-9 |
Fa'aaliga | Pa'epa'e i le pa'epa'e pa'epa'e |
Fuafua mole | C12H15N5O3.H2O |
Molecular Weight | 295.30 |
Fa'aoga | Vasega Pharmaceutical po'o le fa'amoemoega su'esu'e |
afifiina | E tusa ai ma lau talosaga |
Teuina | Fa'asa'o i totonu o koneteina fufusi ma mama i se nofoaga malulu |
Entecavir monohydrate Cas: 209216-23-9 | ||
Aitema | Tulaga | I'uga |
Fa'aaliga | Pa'epa'e i le pa'epa'e pa'epa'e | E usitaia |
Va'aiga mata'utia | +24.0°—+28.0°(DMF:MeOH=1:1 c=1%) | +27.0° |
Fa'ailoaga | A: By IR, Ina ia fetaui ma tulaga faigaluega | E usitaia |
B: I le HPLC, taofi le taimi e tatau ona fetaui ma tulaga faigaluega | E usitaia | |
Vai | 5.8%—6.5% | 6.1% |
Isomer | nofofua ≤0.1% | 0.02% |
Aofa'i ≤0.5% | 0.02% | |
Mea Fa'atatau | Le mama nofofua ≤0.1% | 0.05% |
Aofa'i le mama ≤0.3% | 0.07% | |
Toega ile mu | ≤0.1% | 0.04% |
Metala mamafa | £ 10ppm | E usitaia |
Solivai totoe | E tatau ona fetaui ma le tulaga masani | E usitaia |
Su'ega | ≥99.8% | 99.9% |
Fa'ai'uga:E tusa ai ma tulaga fa'ale-fale. |
Fa'amatalaga a Kamupani
√ Ole poto masani ole pulega ile falegaosimea ma tagata tomai fa'atekinisi; √ O le tulaga lelei e masani lava o la tatou iloiloga maualuga, faiga QC Strict; √ 11 tausaga le poto masani i le auina atu i fafo au faʻatau; √ fale su'esu'e Tuto'atasi; √ Lua fa'aa'oa'oga a le GMP umi saini; √ Mauoa o punaoa o le tele o falegaosimea fa'aletonu mo galuega fa'apitoa; √ Aufaigaluega Maualuga Maualuga ma ala faifai pea.Tusi lau savali iinei ma lafo mai ia i matou