Interpretations of Amendments to Guidelines for Applications of Safety Tests for Injections in Chinese Pharmacopoeia 2025 Edition

doi:10.19803/j.1672-8629.20250648

Abstract

Abstract: Objective To interpret the revised guidelines for applications of safety tests for injections in the Chinese Pharmacopoeia 2025 edition (Volume IV) in order to provide a reference for related applications. Methods The revisions in guidelines 9301 between the 2020 and 2025 editions of the Chinese Pharmacopoeia were compared and contrasted before the amendments were interpreted based on relevant literature at home and abroad. Results This revision focused on alignment with international practices. The principles about safety tests were specified, items for safety testing such as pyrogen testing and abnormal toxicity testing were revised, and details on experiments were elaborated. Raw materials, excipients, and packaging materials that came into direct contact with drugs were described together. Conclusion The revised guidelines have been made compatible with the formation of standards for medical products administration in other countries, and can contribute to standardization and guidance, which is of vital importance for quality control of injections.

Key words: Injections, Safety Test, Chinese Pharmacopoeia 2025 Edition (Volume IV), Guideline 9301, Monocyte Activation Test, Recombinant Factor C, Abnormal Toxicity Test

CLC Number:

R927.1

XU Lin, WU Yanlin, PEI Yusheng, CAI Tong, HUA Xiaodong. Interpretations of Amendments to Guidelines for Applications of Safety Tests for Injections in Chinese Pharmacopoeia 2025 Edition[J]. Chinese Journal of Pharmacovigilance, 2025, 22(11): 1258-1262.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I11/1258

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