In Vitro Tests for Pyrogens in the Pharmacopoeia of the People’s Republic of China (2025 Edition)

doi:10.19803/j.1672-8629.20260140

Abstract

Abstract: Objective To interpret General Requirement 3309 In Vitro Pyrogen Test (a Reporter Gene Assay) in the Pharmacopoeia of the People’s Republic of China (Chinese Pharmacopoeia, ChP) (2025 Edition) so as to provide guidance and references for the application of pyrogen testing methods. Methods By reviewing pharmacopoeias and literature at home and abroad, pyrogen testing methods included in the Chinese Pharmacopoeia (2025 Edition), the European Pharmacopoeia (Ph. Eur. 12.2), and the United States Pharmacopeia (USP-NF 2026 Issue 2) were compared. Furthermore, the scope of application, interference testing, considerations for sample measurement, and system suitability testing specified in General Requirement 3309 In Vitro Pyrogen Test (a Reporter Gene Assay) of the Chinese Pharmacopoeia (2025 Edition) were analyzed. Results The In Vitro Pyrogen Test (a Reporter Gene Assay) stipulated in the Chinese Pharmacopoeia (2025 Edition) was the first to be included in a pharmacopoeia worldwide. The In Vitro Pyrogen Test (a Reporter Gene Assay) filled the gap in reporter gene-based pyrogen testing methods within the regulatory standard system. Conclusion In Vitro Pyrogen Test (a Reporter Gene Assay) is simple to operate, short in experimental cycles (3-6 hours), and able to detect a wide range of pyrogens.However, this method needs to be constantly revised in light of advancements across the globe and domestic practices.

Key words: Pharmacopoeia of the People's Republic of China, Chinese Pharmacopoeia, Pyrogen Test, Reporter Gene Method, General Requirement 3309, Interference Testing

CLC Number:

R954
R917

LI Tiantian, PEI Yusheng, LIU Tao, WANG Can, HE Qing. In Vitro Tests for Pyrogens in the Pharmacopoeia of the People’s Republic of China (2025 Edition)[J]. Chinese Journal of Pharmacovigilance, 2026, 23(6): 663-666.

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https://zgywjj.magtechjournal.com/EN/Y2026/V23/I6/663

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