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號

扎那米韋
CAS號：
139110-80-8

產(chǎn)品介紹：
扎那米韋（INN）是一種神經(jīng)氨酸酶抑制劑，用于治療和預防由A型和B型流感病毒引起的感冒。扎那米韋是個商業(yè)開發(fā)成功的神經(jīng)氨酸酶抑制劑 。扎那米韋是目前市場上由葛蘭素史克公司開發(fā)的商品名為“樂感清”口腔吸入粉末的有效成分。

先聲藥業(yè)的扎那米韋原料藥：
    2006年，先聲藥業(yè)獲得葛蘭素史克公司授權(quán)生產(chǎn)抗流感藥物扎那米韋，是中國唯一一家獲此授權(quán)的制藥企業(yè)。
先聲藥業(yè)的扎那米韋原料藥和制劑成功通過了SFDA的GMP認證。

一些產(chǎn)品參數(shù)
產(chǎn)品標準 CP
性    狀 白色或類白色結(jié)晶性粉末
比 旋 度 +37.7o
酸    度 5.6
氯化物         小于0.02%
細菌總數(shù) 小于100 cfu/g
霉菌與酵母菌總數(shù) 小于10 cfu/g
大腸埃希菌 不得檢出
銅綠假單胞菌 不得檢出
金黃色葡萄球菌 不得檢出
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