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

I-10-DAB Semi-synthetic Paclitaxel GMP API Medicine Paclitaxel Isithombe Esifakiwe
  • I-10-DAB Semi-synthetic Paclitaxel GMP API Medicine Paclitaxel
  • I-10-DAB Semi-synthetic Paclitaxel GMP API Medicine Paclitaxel
  • I-10-DAB Semi-synthetic Paclitaxel GMP API Medicine Paclitaxel
  • I-10-DAB Semi-synthetic Paclitaxel GMP API Medicine Paclitaxel

Incazelo emfushane:

I-Paclitaxel iyinhlanganisela ye-monomeric diterpenoid alkaloid etholakala kuhlobo lwe-Taxus.I-crystalline powder emhlophe, inyibilika kancane emanzini, futhi inyibilika kalula kuzincibilikisi zemvelo ezifana ne-chloroform ne-acetone.Inomsebenzi omuhle wokulwa nomdlavuza, ikakhulukazi kuma-metastases athuthukile.Umdlavuza wesibeletho socansi, umdlavuza webele, umdlavuza wamaphaphu unomphumela obaluleke kakhulu.Njengamanje, i-paclitaxel ihlukaniswe yaba yi-paclitaxel yemvelo kanye ne-10-DAB semi-synthetic paclitaxel.


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Ulwazi Lomkhiqizo

Igama:10-DAT Semi-synthetic Paclitaxel

Inombolo ye-CAS:33069-62-4

Ifomula yekhemikhali:I-C47H51NO14

Imininingwane:99%-102%

Umbala:impushana emhlophe noma ecishe ibe mhlophe

Umthombo:I-Taxus yunnanensis, i-Taxus chinensis

Uhlobo:Ama-API

Umlando we-Hande GMP

1.Ngo-1996, kwasungulwa uhlelo lwekhwalithi futhi lwatholwa i-DMF.

2.Ngo-2004, i-FDA yokuhlola indawo yathola isitifiketi se-CGMP.

3.Ngo-2009, kwatholakala i-semi-synthetic paclitaxel DMF kanye ne-natural paclitaxel CEP.

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

5.Ngo-2012, yaphumelela ukuhlolwa kwe-TGA endaweni, yathola isitifiketi se-GMP, futhi yaphumelela ukuhlolwa kwe-FDA endaweni.

6.Ngo-2013, yadlula indawo ye-CGMP.

7.Ngo-2015, i-India yabhaliswa futhi i-Japan yabhaliswa.

Umthamo wokukhiqiza we-Hande

Umthamo wesandla:600-800kg / ngonyaka

Izinkonzo Zethu

1.Imikhiqizo:Nikeza ngezingcaphuno zezitshalo zekhwalithi ephezulu, ezihlanzeke kakhulu, izinto zokusetshenziswa zemithi, nezimaphakathi zemithi.

2.Izinsizakalo zobuchwepheshe:Izingcaphuno ezenziwe ngokwezifiso ezinemininingwane ekhethekile ngokuya ngezidingo zekhasimende.

Imboni yezandla

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