USP EP BP Daawada Fasalka 148408-66-6 Docetaxel trihydrate ee Daaweynta Kansarka Burada
Alaabtamagac | Docetaxel Trihydrate |
La mid ah | (αR, βS)-β-[[(1,1-dimethylethoxy) karbonyl] amino]-a-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,hydrate (1:3) |
CAS Maya. | 148408-66-6 |
Muuqashada | Caddaan iyo budo crystalline ah |
Qaanuunka molecular | C43H53NO14.3 (H2O) |
Miisaanka Molecular | 861.94 |
Codsiga | Darajada farmashiyaha ama ujeedada cilmi baarista |
Baakad | Sida ku cad codsigaaga |
Kaydinta | Ku kaydi weel cidhiidhi ah oo iftiin u adkaysta meel qabow |
WAXYAABAHA | HEERARKA | NATIIJADA |
Jilayaasha | A: Caddaan iyo budo crystalline ah | waafaqsan |
B: milmi: Biyo ku milma, ku milma ethanol iyo acetone | waafaqsan | |
Gaar ahRotation | ﹣38.5°~﹣41.5° | ﹣40° |
Aqoonsiga | 1.IR: La mid ah si loo hubiyo muunad | waafaqsan |
2.UV: λmax232nm | waafaqsan | |
| waafaqsan | |
| waafaqsan | |
wasakhda | Wadarta wasakhda: NMT 1.0% | 0.29% |
wasakhda A: NMT 0.5% | 0.0551% | |
Wasakhda B: NMT 0.3% | 0.0470% | |
wasakhda C: NMT 0.3% | 0.0535% | |
Mid kasta oo kale oo wasakh ah: NMT 0.1% | 0.0702% | |
Biyo | 5.0% - 7.0% | 6.15% |
Hadhaaga dabka | NMT 0.1% w/w | 0.03% |
Bir culus | NMT 20ppm | waafaqsan |
Qiimayn | 97.5% ~ 102.0% | 99.7% |
Gabagabo | Waxay la kulmeysaa EP7.5. |
Macluumaadka Shirkadda
√ Waayo-aragnimada buuxda ee lakabka maamulka ee warshadda iyo farsamayaqaannada raacsan; √ Tayada had iyo jeer waa tixgelinteena ugu sareysa, nidaamka QC adag; √ 11 sano oo khibrad u leh kooxda iibka dhoofinta; √ shaybaadhka R&D ee madaxa banaan; √ Laba aqoon-is-weydaarsiyo GMP-dheer oo saxeexan; √ Khayraadka hodanka ah ee warshado badan oo shaqo la'aan ah oo loogu talagalay mashruuc la habeeyey; √ Kooxda shaqada oo hufnaan sare leh oo leh waddo joogto ah.Halkan ku qor fariintaada oo noo soo dir