Pharmaceutical Chemical
Biapenem （GMP)
Description
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抯 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
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Simcere Pharmaceutical Group
Diosmectite(Montmorillonite)
Address: No.699-18, Xuanwu Avenue Nanjing, P. R. China,
Nanjing, Jiangsu
China, 210042
Tel: +86 (25) 8556 6666-8851
Fax: +86 (25) 8528 1765
