CERTIFICATION OF ANALYSIS

Size: px

Start display at page:

Download "CERTIFICATION OF ANALYSIS"

儒兽屈
5 years ago
Views:

1 FSP PRODUCT LIST Taxane Product 紫杉烷类产品目录 Code Generic/Product Name 中文品名 Spec GMP/Documentation 901 Paclitaxel,natural Extract from Taxus Wallichiana 902 Paclitaxel,semi-synthetic Starting material:10-dab III 903 Docetaxel.anhydrous CAS: Docetaxel.trihydrous CAS: Deacetyl Baccatin III [10-DAB III] CAS: Extract from both Taxus Wallichiana and Taxus Baccata 897 Cabazitaxel 901 crude CAS: Paclitaxel,natural crude CAS: I1 Baccatin III CAS: N-1 7-Troc Paclitaxel CAS: N Di Troc Docetaxel 903-AC CAS No.: Ac Docetaxel CAS No.: Cephalomannine CAS No.: Deacetyl Paclitaxel CAS No.: I4 7,10-dimethoxy-10-DAB III CAS No.: 天然紫杉醇半合成紫杉醇无水多西他赛 EP9.0,USP39, EP9.0,USP39, EP9.0, 三水多西他赛 EP9.0,USP39 DMF 10- 脱乙酰基巴卡丁三 USDMF#23558 USDMF# USDMF # % USDMF #25294 卡巴他赛 Validation 天然紫杉醇粗品 10%, 70% CMC 巴卡丁三 CMC 7- 三氯乙氧羰基紫杉醇 7,10- 双三氯乙氧羰基多西他赛 2'- 乙酰基多西他赛 CMC CMC CMC 三尖杉宁碱 96% CMC 10- 脱乙酰基紫杉醇 7,10- 二甲氧基 10- 脱乙酰基巴卡丁三 CMC 98.5% CMC 1 / 5

2 Code Taxane Side Chain 紫杉烷侧链 Chemical Name/CAS number 910-D (4S,5R)-3-(tert-Butoxycarbonyl)-2,2-dimethyl-4-phenyloxazolidine-5-carboxylic acid CAS: (4S,5R)-2,4-diphenyl-4,5-dihydrooxazole-5-carboxylic acid CAS: (4S,5R)-3-Benzoyl-2-(4-methoxyphenyl)-4-phenyl-5-oxazolidinecarboxylic acid CAS: (4S,5R)-3-tert-butoxycarbony-2-(4-anisyl)-4-phenyl-5-oxazolidinecarboxylic acid CAS: Methyl (2R,3S)-N-Benzoyl-3- Phenylisoserine CAS: P (3R,4S)-3-triethylsilanyloxy-4-phenyl-N-benzoyl-2-azetidinone CAS: D (3R,4S)-3-triethylsilanyloxy-4-phenyl-N-Boc-2-azetidinone CAS: I3 (3R,4S)-3-hydroxy-4-phenyl-azetidin-2-one CAS: (3R,4S)-3-(1-ethoxyethoxy)-4-phenyl-N-benzoyl-2-azetidinone CAS: (3R,4S)-3-(1-ethoxyethoxy)-4-phenyl-N-Boc-2-azetidinone CAS: *Purity, Tech package available 2 / 5

3 API product list, besides Taxane 其他原料药产品目录 Code Generic/Product Name 中文名称 Spec Remarks 801 Letrozole 来曲唑 99.5% 805 Chlorambucil 苯丁酸氮芥 V 806 Melphalan 美法仑 V 808 Temozolomide 替莫唑胺 809 Imatinib Mesylate 伊马替尼 EP9.2, 99.9% 100% α β form 829 Erlotinib hydrochloride 厄洛替尼 99.5% A form,b form 850 Decitabine HCL 地西他滨 V 852 Fludarabine phosphate 氟达拉滨磷酸盐 V 869 Irinotecan HCL trihydrate 盐酸伊立替康 V 893 Bendamustine HCL CAS: 苯达莫司汀 USP39, CP, B form, 99.5% ALA HCL(5-ALA) 五氨基酮戊酸盐酸盐 99% V DMF available V under commercial validation API under R&D 研发品种 Bortezomib 硼替佐米 Sunitinib 苏尼替尼 Defreasirox 地拉罗司 Diacerein 双醋瑞因 Tamsulosin 坦索罗辛 Minodronic acid 米诺膦酸 Ixazomib 爱莎佐米 Nilotinib 尼罗替尼 Omacetaxine Mepesuccinate 高三尖杉酯碱 Delamanid 迪拉马尼 Dorzolamide 多佐胺 FINISHED DOSAGE FORMULATION,FDF 制剂产品 Code Product Name Strength GMP status 809T Imatinib Mesylate tablet 100mg BE license received 801T Letrozole tablet 2.5 mg BE license received 829T Erlotinib hydrochloride tablet 100mg/150mg BE license received 808T Temozolomide capsule 20mg/100mg Filing Manufacturer: Fujian South Pharmaceutical Co., Ltd 3 / 5

4 Pharmaceutical Intermediates 医药中间体 Nilotinib intermediate 813-I1 3-(dimethylamino)-1-(3-pyridinyl)-2-propen-1-one CAS: I2 3-[(aminoiminomethyl)amino]-4-methyl-benzoic acid methyl ester nitrate CAS: Sunitinib intermediate 816-I2 5-Fluoroisatin CAS: I5 5-Fluoro oxindole CAS: I9 5-Formyl-2,4-dimethyl-1H-pyrrole-3 -carboxylic acid CAS: Nintedanib intermediate 133 Methyl oxindole-6-carboxylate T8 T6 CAS#: Gemcitabine intermediate 2-Deoxy-2,2-difluoro-D-erythro-pentofuranose-3,5-dibenzoate-1-methanesu lfonate CAS: Deoxy-2,2-difluoro-D-erythro-pentafuranous-1-ulose-3,5-dibenzoate CAS: Bortezomib Intermediate 859-I1 2-Pyrazinecarboxylic acid CAS: Formoterol Intermediate Bromo-4'-Benzyloxy-3'-nitroacetophenone CAS: Other Intermediate Aminoethanesulfonamide HCL CAS: [4-(4-methyl-1-piperazinyl)-1-piperidinyl]Benzenamine CAS: B Fludarabine base CAS: * Tech package available Spec 99.5% 99% 98.0% 70%, 99% 4 / 5

5 No 序号 Botanic Extract product list 植物来源产品目录 Botanic source 植物来源 Grape seed Extracts 葡萄籽提取物 Stevia Extracts 甜叶菊提取物 Ginkgo Biloba Extracts 银杏提取物 Polygonum cuspidatum 虎杖提取物 Ginseng Extract 人参提取物 Tea 茶 Maca 玛咖 Sarcandra Glabra Extract 草珊瑚提取物 Aloe Vera 芦荟提取物 Product name 产品名称 Spec 规格 OPC 原花青素 PPC 低聚原花青素 Grape seed oil Food grade 葡萄籽油食品级 Stevioside 甜菊糖苷 Rebaudioside-A 莱鲍迪苷 A Flavonoids 银杏黄酮 Terpene Lactones A 银杏内脂 A Resveratrol 白藜芦醇 50% Re 50% Rd 50% Rg1 50% Decaffeinated tea Food grade 脱咖啡因茶食品级 Maca and Maca Extract 玛咖和玛咖提取物 5:1, 10:1, 20:1,powder 10:1,20:1,powder Aloe Emodin 芦荟大黄素 50%,95% Note: All the above products are not offered for sale in countries and regions where the sale of such products constitutes a patent infringement, and liability for patent infringement is exclusively understood at buyer s risk. Product is offered for R&D use in accordance with (i) 35 USC 271(e)+A13(1) in the U.S.; (ii) Section 69.1 of Japanese Patent Law in Japan; (iii) Section 11, No. 2 of the German Patent Act of 1981 in Germany,etc. 5 / 5

20 氟尿嘧啶 Fluorouracil 口服乳剂乳膏植入剂口服溶液,,oral emulsion,cream,implant s,oral liquide 氟他胺 Flutamide 胶囊, 22 氟维司群 Fulvestrant 23 福美坦 Formestane

20 氟尿嘧啶 Fluorouracil 口服乳剂乳膏植入剂口服溶液,,oral emulsion,cream,implant s,oral liquide 氟他胺 Flutamide 胶囊, 22 氟维司群 Fulvestrant 23 福美坦 Formestane 附件序号 Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 抗癌药品清单 ( 第一批 ) Anticancer drugs list(the 1st phase) 一抗癌药品制剂 1.Anticancer drugs finished dosages 药品活性成分名称 APIs Name 阿那曲唑 Anastrozole 阿糖胞苷 Cytarabine