1. Shandong Institute for Food and Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs, Shandong Research Center of Engineering and Technology for Consistency Evaluation of Generic Drugs, Jinan 250101, China; 2. Chinese Pharmacopoeia Commission, Beijing 100061, China
Abstract：OBJECTIVE To explore the guidelines for quality control of bacterial endotoxin for pharmaceutical excipients and standard styles in Chinese Pharmacopeia. METHODS Based on the status survey and the international progress, the existing problems in China were analyzed, and the guiding principles and standard styles of bacterial endotoxin standard for pharmaceutical excipients were proposed. RESULTS Based on the characteristics and usage of excipients, we discussed the setting of endotoxin specifications for pharmaceutical excipients, the calculation of the endotoxin limits, and the control strategy of bacterial endotoxin during the manufacturing of parenteral products. The styles for standard specifications in Chinese Pharmacopeia were also advised. CONCLUSION The guidelines and normative requirements for quality control and standard research of bacterial endotoxin for pharmaceutical excipients are put forward for the first time,which is helpful to improve the quality standard system of pharmaceutical excipients and ensure the safety of drugs under the situation of the associated review and approval policy in China.
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2023, Vol. 58 
