Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Tianyin Pharmaceutical's Jiangchuan Macrolide Facility (JCM) has passed the internal quality assessment for first batch production of its Azithromycin active pharmaceutical ingredients (API).
Subscribe to our email newsletter
A series of data points including intermediates contents, purity, quality, stability and stereochemistry were collected and compared it with the national standard of Azithromycin API that were issued in the latest version (2010) of Pharmacopoeia of China.
During the production process, various parameters for quality control purposes were also measured.
The results demonstrated that erthromycin API made at JCM has met the quality standards stipulated by China’s State Food and Drug Administration (SFDA).
Azithromycin is a macrolide antibiotic related to erythromycin which is used to treat various bacterial infections caused by respiratory pathogens, such as Aerobic gram-positive microorganisms and gram-negative microorganisms.