China worries a lot about Endotoxin
China participated in early BioNTech Pfizer Covid19 Jab trials but did not mass jab its citizens because it was worried about the Endotoxin Fever in trial subjects
In an earlier article I pointed out why China rejected the BioNTech Pfizer Covid19 Jabs. The reason was the Endotoxin Fever in trial subjects.1
My recent deep dive into the European Union database yielded some interesting slides from presentations at conferences on pharmaceutical quality control.
Director and Professor Huimin Sun of the National Institutes for Food and Drug Control (NIFDC), CFDA 中国食品药品检定研究院 Institute for Packaging Materials and Pharmaceutical Excipients Control 包装材料与药用辅料检定所 spoke about the inadequacy of Activated Charcoal for removing Nanoparticles and shows a limit of 2 EU per gram as a filter at a conference in France.2
Professor Huimin Sun was also worried about Endotoxin contamination of Polysorbate 80 and appears to specify a limit of 0.012 EU/ml.
Professor Huimin Sun called for nw limits on Endotoxin and other contaminants to be added to Quality Control Monographs for Hydroxypropyl β cyclodextrin that is used as a solubilizer.
Please let me know if you find more information on Endotoxin limits in China.
Huimin Sun 孙会敏. 18 Sep 2018. Risks, classifying management and technical requirements for pharmaceutical excipients. Presentation 4 in What’s New in the field of Excipients in China? EDQM France.