扎那米韦（GMP)

Zanamivir
CAS:
139110-80-8

Introduction:
Zanamivir ( INN ) is a neuraminidase inhibitor used in the treatment and prophylaxis of influenza caused by influenza A virus and influenza B virus . Zanamivir was the first neuraminidase inhibitor commercially developed. It is currently marketed by GlaxoSmithKline under the trade name Relenza as a powder for oral inhalation.

Simcere's Zanamivir API:
In 2006 Simcere was granted a license by GlaxoSmithKline to make products containing Zanamivir, Simcere is the only pharmaceutical company in mainland China that has such a license.
The API materials and preparations of Zanamivir are both successfully passed and received SFDA GMP certification.

Some inspection data
Specification             CP
Properties               White or off white crystalline powder
Specific rotation        +37.7o
PH                        5.6
Chloride                        0.02% max
Total bacteria            100 cfu/g max
Yeasts and Moulds        10 cfu/g max
Escherichia coli         Not detected
Pseudomonas aeruginosa          Not detected
Staphylococcus aureus     Not detected
Assay                     98% Min

Keyword: Zanamivir, Relenza , Antiviral, Influenza,139110-80-8

南京市玄武大道699-18号

扎那米韦
CAS号：
139110-80-8

产品介绍：
扎那米韦（INN）是一种神经氨酸酶抑制剂，用于治疗和预防由A型和B型流感病毒引起的感冒。扎那米韦是个商业开发成功的神经氨酸酶抑制剂 。扎那米韦是目前市场上由葛兰素史克公司开发的商品名为“乐感清”口腔吸入粉末的有效成分。

先声药业的扎那米韦原料药：
    2006年，先声药业获得葛兰素史克公司授权生产抗流感药物扎那米韦，是中国唯一一家获此授权的制药企业。
先声药业的扎那米韦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 白色或类白色结晶性粉末
比 旋 度 +37.7o
酸    度 5.6
氯化物         小于0.02%
细菌总数 小于100 cfu/g
霉菌与酵母菌总数 小于10 cfu/g
大肠埃希菌 不得检出
铜绿假单胞菌 不得检出
金黄色葡萄球菌 不得检出
含量 98% Min

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
www.simcere.com