I-10-DAB Semi-synthetic Paclitaxel GMP API Medicine Paclitaxel

Inkcazelo emfutshane:

I-Paclitaxel yi-monomeric diterpenoid alkaloid ikhompawundi ephuma kwi-Taxus genus.Ngumgubo omhlophe wekristale, unyibilika kancinane emanzini, kwaye unyibilika ngokulula kwizinyibilikisi eziphilayo ezifana nekloroform kunye neacetone.Inomsebenzi olungileyo wokulwa nomhlaza, ngakumbi kwiimetastases eziphambili.Umhlaza wesibeleko se-ovarian, umhlaza wamabele, umhlaza wemiphunga unempembelelo ebaluleke kakhulu.Okwangoku, i-paclitaxel yahlulwe kwi-paclitaxel yendalo kunye ne-10-DAB semi-synthetic paclitaxel.


Iinkcukacha zeMveliso

Iithegi zeMveliso

Ulwazi ngeMveliso

Igama:10-DAT Semi-synthetic Paclitaxel

Inombolo yeCAS:33069-62-4

Ifomula yemichiza:C47H51NO14

Iinkcukacha:99%-102%

Umbala:umgubo omhlophe okanye phantse omhlophe

Umthombo:Taxus yunnanensis,Taxus chinensis

Uhlobo:APIs

Imbali ye-Hande GMP

1.Ngo-1996, inkqubo yomgangatho yasekwa kwaye yafunyanwa i-DMF.

2.Ngo-2004, uhlolo lwe-FDA kwisiza lufumene isatifikethi seCGMP.

3.Ngo-2009, i-semi-synthetic paclitaxel DMF kunye ne-CEP yendalo ye-paclitaxel yafunyanwa.

4.Ngo-2011, i-semi-synthetic paclitaxel CEP yafunyanwa.

5.Ngo-2012, iphumelele uhlolo lwe-TGA kwindawo, yafumana isatifikethi se-GMP, kwaye yaphumelela uhlolo lwe-FDA kwindawo.

6.Ngo-2013, yadlula indawo yeCGMP.

7.Ngo-2015, iIndiya yabhaliswa kwaye iJapan yabhaliswa.

Umthamo wemveliso yesandla

Umthamo wesandla:600-800kg / ngonyaka

Iinkonzo zethu

1.Iimveliso:Ukubonelela ngomgangatho ophezulu, izicatshulwa zezityalo ezisulungekileyo, imathiriyeli ekrwada yamayeza, kunye nabaphakathi bamayeza.

2.Iinkonzo zobugcisa:Izicatshulwa ezenziwe ngokwezifiso ezineenkcazo ezizodwa ngokweemfuno zabathengi.

Umzi-mveliso we-Hande

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