10-DAB Semi-synthetic Paclitaxel GMP API Medicine Paclitaxel

Kufotokozera Kwachidule:

Paclitaxel ndi gulu la monomeric diterpenoid alkaloid lochokera ku mtundu wa Taxus.Ndi ufa wa crystalline woyera, wosungunuka pang'ono m'madzi, ndipo umasungunuka mosavuta mu zosungunulira za organic monga chloroform ndi acetone.Ili ndi ntchito yabwino yolimbana ndi khansa, makamaka ya metastases yapamwamba.Khansara ya ovarian yogonana, khansa ya m'mawere, khansa ya m'mapapo imakhala ndi zotsatira zazikulu.Pakadali pano, paclitaxel imagawidwa kukhala paclitaxel yachilengedwe ndi 10-DAB semi-synthetic paclitaxel.


Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

Zambiri Zamalonda

Dzina:10-DAT Semi-synthetic Paclitaxel

Nambala ya CAS:33069-62-4

Chemical formula:C47H51NO14

Zofotokozera:99% -102%

Mtundu:woyera kapena pafupifupi ufa woyera

Gwero:Taxus yunnanensis, Taxus chinensis

Mtundu:APIs

Mbiri ya Hande GMP

1.Mu 1996, dongosolo labwino linakhazikitsidwa ndikupeza DMF.

2.Mu 2004, FDA poyang'anira malo adapeza satifiketi ya CGMP.

3.Mu 2009, semi-synthetic paclitaxel DMF ndi paclitaxel CEP zachilengedwe zidapezeka.

4.Mu 2011, semi-synthetic paclitaxel CEP idapezeka.

5.Mu 2012, idadutsa kuyendera kwa TGA pamalopo, idalandira chiphaso cha GMP, ndipo idadutsa kuyendera kwa FDA pamalowo.

6.Mu 2013, adadutsa tsamba la CGMP.

7.Mu 2015, India idalembetsedwa ndipo Japan idalembetsedwa.

Kuthekera kopanga zamanja

Kuchuluka kwa mano:600-800kg / chaka

Ntchito Zathu

1.Zogulitsa:Perekani zokometsera zapamwamba kwambiri, zoyera kwambiri, zopangira mankhwala, komanso zopangira mankhwala.

2.Ntchito zaukadaulo:Makonda akupanga ndi specifications wapadera malinga ndi zofunika kasitomala.

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