Biapenem
CAS:
120410-24-4

Introduction:
Biapenem is a new parenteral carbapenem antibacterial agent with a broad spectrum of in vitro antibacterial activity encompassing many Gram-negative and Gram-positive aerobic and anaerobic bacteria, including species producing β-lactamases. It was approved in Japan in 2001.

Simcere's Biapenem API:
In 2008, Simcere’s Anxin is the first-to-market Biapenem injection in China.
The API materials and preparations of Biapenem are both successfully passed and received SFDA GMP certification.

Some inspection data
Specification    CP/Sterile bulk drugs
Properties       White or yellow crystalline powder
Specific rotation -33.0°
Acidity          5.3
Loss on drying    0.04%
Residue on ignition 0.01%
Chloride         0.05% max
Heavy metals     10ppm max
Bacterial endotoxin 0.5EU/mg max
Assay            97% min

Keyword: Biapenem, 120410-24-4

比阿培南

CAS號：
120410-24-4

產(chǎn)品介紹：
比阿培南是一種非腸道吸收的廣譜碳青霉烯類抗生素，其體外實驗表明，其對許多包括革蘭陰性和革蘭氏陽性需氧菌和厭氧菌有效，其中包括產(chǎn)β-內(nèi)酰胺酶菌株。日本于2001年批準上市。

先聲藥業(yè)的比阿培南原料藥：
2008年，先聲藥業(yè)將比阿培南注射液——安信在中國首家上市。
先聲藥業(yè)的比阿培南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/無菌原料藥
性    狀 白色或類白色結(jié)晶粉末
比 旋 度 -33.0°
酸    度 5.3
干燥失重 0.04%
熾灼殘渣 0.01%
氯 化 物 0.05% max
重 金 屬 10 ppm max
細菌內(nèi)毒素 0.5EU/1mg max
含    量     97% min

關(guān)鍵詞: 比阿培南，120410-24-4

Simcere Bulk Pharmaceuticals Division
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