Interpretations of Revised Bioassay of Follicle-Stimulating Hormone in Chinese Pharmacopoeia 2025

doi:10.19803/j.1672-8629.20250537

Abstract

Abstract: Objective To interpret the newly added and revised bioassay methods for the determination of bioactivity of follicle-stimulating hormone (FSH) in the Chinese Pharmacopoeia (2025 edition), and to conduct a comparative study on the refinement and standardization of these methods so as to facilitate the understanding and implementation of these standards. Methods An overview of the revisions of and additions to FSH bioassay methods was given. By elaborating on the process of drafting the additions of and revisions to the methods, the necessity and feasibility of the newly added methods were explained. Results The newly added methods in the Chinese Pharmacopoeia (2025 Edition), namely Method Two of 1216 FSH Biological Activity Determination and Method 3536 for Human FSH Biological Activity Determination, were both cell response methods. They were characterized by a high sensitivity, good specificity, high accuracy, and good consistency with the current standards. Conclusion The newly added methods for the determination of the FSH biological activity in the Chinese Pharmacopoeia (2025 Edition) is the first of its kind globally in the field of FSH activity determination. The progress in methods for FSH biological activity determination will help improve quality control of FSH products.

Key words: 2025 Edition of the Chinese Pharmacopoeia, Follicle Stimulating Hormone, Biological Activity Determination Method, Potency, Granulosa Cell, in vitro Assay Method

CLC Number:

R927.1

WU Yanlin, WEN Miao, YANG Ze'an, ZHANG Yuan, HE Qing. Interpretations of Revised Bioassay of Follicle-Stimulating Hormone in Chinese Pharmacopoeia 2025[J]. Chinese Journal of Pharmacovigilance, 2025, 22(10): 1132-1136.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I10/1132

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