USP EP BP Vailaau Fa'afomai 148408-66-6 Docetaxel trihydrate mo Togafitiga o le Kanesa Tumor
Oloaigoa | Docetaxel Trihydrate |
Synonyms | (αR,βS)-β-[[(1,1-dimethylethoxy)carbonyl]amino]-α-hydroxy-benzenepropanoic acid, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b -(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13 ,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl ester,susu (1:3) |
CAS Nu. | 148408-66-6 |
Fa'aaliga | Pa'epa'e i le pa'epa'e pa'epa'e tioata |
Fuafua mole | C43H53NO14.3(H2O) |
Molecular Weight | 861.94 |
Fa'atatauga | Vasega Pharma po'o le fa'amoemoega o su'esu'ega |
afifiina | E tusa ai ma lau talosaga |
Teuina | Fa'asa'o i totonu o koneteina fufusi ma mama i se nofoaga malulu |
MEA | TULAGA | I'UGA |
Uiga | A: Pa'epa'e i le pa'epa'e pa'epa'e tioata | Fa'atatau |
B:Solubility: E le mafai ona solu ile vai, solu ile ethanol ma le acetone | Fa'atatau | |
Fa'apitoaRfa'auiga | ﹣38.5°~﹣41.5° | ﹣40° |
Fa'ailoaga | 1.IR: Le tutusa e siaki faʻataʻitaʻiga | Fa'atatau |
2.UV: λmax232nm | Fa'atatau | |
| Fa'atatau | |
| Fa'atatau | |
mea leaga | Aofa'i le mama: NMT 1.0% | 0.29% |
Fa'aleaga A: NMT 0.5% | 0.0551% | |
Fa'aleaga B: NMT 0.3% | 0.0470% | |
Fa'aleaga C: NMT 0.3% | 0.0535% | |
So'o se isi mea leaga e tasi: NMT 0.1% | 0.0702% | |
Vai | 5.0% – 7.0% | 6.15% |
Toega ile mu | NMT 0.1% w/w | 0.03% |
Uamea mamafa | NMT 20ppm | Fa'atatau |
Su'ega | 97.5%~ 102.0% | 99.7% |
Fa'ai'uga | E fetaui ma le EP7.5. |
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