比阿培南（GMP)

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号：
120410-24-4

产品介绍：
比阿培南是一种非肠道吸收的广谱碳青霉烯类抗生素，其体外实验表明，其对许多包括革兰阴性和革兰氏阳性需氧菌和厌氧菌有效，其中包括产β-内酰胺酶菌株。日本于2001年批准上市。

先声药业的比阿培南原料药：
2008年，先声药业将比阿培南注射液——安信在中国首家上市。
先声药业的比阿培南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/无菌原料药
性    状 白色或类白色结晶粉末
比 旋 度 -33.0°
酸    度 5.3
干燥失重 0.04%
炽灼残渣 0.01%
氯 化 物 0.05% max
重 金 属 10 ppm max
细菌内毒素 0.5EU/1mg max
含    量     97% min

关键词: 比阿培南，120410-24-4

Simcere Bulk Pharmaceuticals Division
Address：No.699-18, Xuanwu Avenue Nanjing, P. R. China，210042
TEL:     +86 (25) 8556 6666-8851
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