奈达铂（GMP)

Nedaplatin

CAS:
95734-82-0

Introduction:
Nedaplatin is a platinum compound which is used for cancer chemotherapy, It is a derivative of cisplatin, but It produces less nausea, vomiting and nephrotoxicity than cisplatin. Nedaplatin is primarily used in patients with the cancer of head and neck, small cell lung carcinoma, non-small-cell lung carcinoma, esophageal cancer, and other solid tumors.

Simcere's Nedaplatin API:
Simcere’s JIebaishu is the first marketed injection of Nedaplatin in China.
Simcere’s API and preparations of Nedaplatin are both successfully passed and received SFDA GMP certification.

Some inspection data
Specification    CP
Properties       Off white or yellowish crystalline powder
PH               6.6
Loss on drying    0.5% max
Total bacteria   100 cfu/g max
Yeasts and Moulds 10 cfu/g max
Escherichia coli Not detected
Assay            99.6 %

Keyword: Nedaplatin, 95734-82-0

奈达铂

奈达铂
CAS号：
95734-82-0

产品介绍：
奈达铂是一种用于癌症化疗的铂类化合物，它是顺铂的衍生物，但与顺铂相比，其副作用如恶心，呕吐和肾毒性等更轻。目前奈达铂主要用于头部和颈部癌症，小细胞肺癌，非小细胞肺癌，食管癌以及其他实体瘤化疗.

先声药业的奈达铂原料药：
2008年，先声药业将奈达铂注射液——捷佰舒在中国首家上市。
先声药业的奈达铂原料药和制剂成功通过了SFDA的GMP认证。

一些产品参数
产品标准         CP
性    状         类白色或微黄色结晶性粉末
酸 碱 度           6.6
干燥失重         小于0.5%
细 菌 数           小于100cfu/g
霉菌与酵母菌数    小于10cfu/g
大肠埃希菌       不得检出
含    量             99.6%

关键词:  奈达铂, 顺-甘醇酸二氨合铂, 顺糖氨铂, 95734-82-0

Simcere Bulk Pharmaceuticals Division
Address：No.699-18, Xuanwu Avenue Nanjing, P. R. China，210042
TEL:     +86 (25) 8556 6666-8851
        Fax:     +86 (25) 8528 1765
E-mail:  yuanliaoyao@simcere.com
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