Interpretation for the General Chapter 0237 the preparation and establishment of national biological reference standards in Chinese Pharmacopoeia 2025 Edition Volume Ⅲ
10.19778/j.chp.2025.01.014
- VernacularTitle:2025年版《中国药典》三部通则0237国家生物标准物质研制解读
- Author:
WANG Yiping
;
MAO Qunying
;
WANG Xiaojuan
;
LIANG Zhenglun
- Publication Type:Journal Article
- Keywords:
national biological reference standards;
preparation;
collaborative calibration;
commutability;
stability
- From:
Drug Standards of China
2025;26(1):099-104
- CountryChina
- Language:Chinese
-
Abstract:
The Chinese Pharmacopoeia 2025 Edition is about to be officially released. Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission, has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ. General chapter 0237, integrating the cutting-edge concepts from WHO’s related guidelines and the practical experience of biological reference standards both domestically, has revised the names of this chapter, updated and improved the technical requirements for candidate reference materials, collaborative calibration and value assignment, as well as stability research and monitoring. It also newly proposes the calculation of uncertainty of biological reference materials and emphasizes to pay attention to commutability. The implementation of general chapter 0237 will play a guiding role in improving the research and application level of biological reference materials in China. This article, by interpreting the revised content of general chapter 0237, aims to provide a reference for the researchers of biological reference materials.
- Full text:202503111433022194120250214.pdf
