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The bacterial endotoxin test in the Chinese pharmacopoeia: A journey of international harmonization and national consideration | Synapse
March 3, 2026
The bacterial endotoxin test in the Chinese pharmacopoeia: A journey of international harmonization and national consideration
TC
Tong Cai
YP
Yusheng Pei
National Institutes for Food and Drug Control
Key Points
This journey highlights the evolution of bacterial endotoxin testing standards in pharmacopoeias.
Significant collaboration in international harmonization enhances quality control practices globally.
Analysis of current testing methods reveals variations and consolidates national interests in regulation.
Efforts support the need for consistent quality in pharmaceutical products, ensuring safety across markets.
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Cai et al. (Thu,) studied this question.
synapsesocial.com/papers/69a75dbfc6e9836116a27f9f
https://doi.org/https://doi.org/10.1016/j.mimet.2026.107411