1、中文名:比卡鲁胺
2、英文名称:Bicalutamide
3、CAS:90357-06-5
4、25kg/drum
5、CDE平台登记号:Y20190000245
6、与制剂共同审评审批结果:I
7、原料药
8、药品生产许可证 许可生产范围内产品
9、有药监局出口欧盟原料药证明文件
10、CEP认证
1.CAS RN: 90357-06-5
2.English Name:Bicalutimide
Chemical name: N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxyl-2- methylpropanemide
Synonyms: Bicalutamide (Subject to patent free); 4-cyano-3-trifluoromethyl-N-(3-p-fluorophenylsulfonyl-2-hydroxy-2-methylpropionyl)aniline; N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(4-fluorophenyl)sulfonyl-2-hydroxy-2-methyl-propanamid; [(4- fluorophenyl) sulfonyl]-2-hydroxy- 2-methyl propanamide ; N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide; (2S)-N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide
3. Structural Formula:
4. Molecular formula & molecular weight: C18H14F4N2O4S 430.38
5. Characters: It’s a white or almost white crystal powder, odorless, tasteless, freely soluble in DMF; Soluble in butylene oxide; sparingly soluble in acetic ether and methanol; insoluble in water.
6. Quality Standard: Enterprise standard : USP43
7. Usage: Prostate drug, It is developed by AstraZenca Internatioal,and it is the first antiandrogen non-corticosteroids drug for long-acting oral medication and firstly go on the market in 1995 in UK. An antiandrogen non-corticosteroids can be used treating prostate cancer in advanced stage as assistant drug, may also for treating prostate cancer in the early stage to play an important role.
8. Storage: It should be kept in room temperature, and away from light; stored in sealed containers.
9. Packing: paper bucket, 25kg/package.
10.Supply Ability: 800kg /month
11. HS CODE: 29309090.90
关键字: 比卡鲁胺;比卡鲁胺Bicalutamide;90357-06-5;
陕西大生制药科技有限公司,地处中国西安高新技术产业开发区,属高新技术企业。公司成立于2001年,拥有自建生产基地、《药品生产许可证》、《排污许可证》,专业从事医药原料药及中间体、化工产品的研制、生产和销售。
其中原料药盐酸莫西沙星、葡萄糖酸钙、葡萄糖酸钠、膦甲酸钠、甘油、硝酸甘油溶液、葡萄糖酸氯己定溶液、醋酸氯己定、盐酸氯己定、聚甲酚磺醛(GMP、WC)等十多个产品已通过了GMP符合性检查;
盐酸丙卡特罗(I状态)、比卡鲁胺(I状态、CEP)、托吡酯、磺基苯乙酸、N-乙酰甘氨酸,聚六亚甲基双胍盐酸盐(PHMB)、阿仑膦酸钠等其他产品均按高标准生产制造。
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质量控制中心拥有Waters、Agilent、Shimadzu等国际一流分析仪器,同时我们拥有专业的研发和质量保证团队。
我们秉持“走正道,做工匠,做专做精”的精神,苦炼内功,严格执行GMP规范,分别与行业龙头企业合作多年,产品广泛出口欧美、中东、东南亚等市场。部分产品正在欧、美、日进行注册。我们愿以持续稳定的生产和高标准的质量,以及完善的环境保护体系,为您提供可靠的产品和服务,努力做全球优质供应商!
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