RESUMEN
To analyze the major changes and existing problems of bioassay methodrelated to specifications of biochemicalsin the Chinese Pharmacopoeia 2015 edition and to discuss the trend of the quality control of biochemical and bioassay method improved
RESUMEN
The article introduces the main changes related to specifications of antibiotics in the Chinese Pharmacopoeia 2015, and discusses the trend of the quality control of antibiotics. The main strategy of antibiotic quality control in this edition of Chinese Pharmacopoeia has been changed to chemical analysis, with biological assay as auxiliary. The revision not only keeps in line with international standards, but also fully reflects the status of domestic antibiotic manufacturing and the quality control level. Solving the key points of specifications of antibiotics through development of new technologies and analysis methods is the trend in the field of antibiotic control in China.