[A proposal by the Japanese Pharmacopoeia for a method to set an endotoxin limit for parenteral drugs to be tested].
The Bacterial Endotoxins Test has been extensively revised in the JP 13. In addition to the limit test with gelation, adopted in the JP 12, quantitative methods using gel-clot, turbidimetric and chromogenic techniques have been adopted in the JP 13. As for the endotoxin limit for monographs, it was specified for Water for Injection alone in the JP 12. Since the issue of the JP 13 Supplement is under consideration, the possibility of replacing the Pyrogen Test (which is required for some main products in the current JP 13 monographs) with the Bacterial Endotoxins Test is now being discussed. For international harmonization of the Bacterial Endotoxins Test, it seems to be preferable to follow (if acceptable) the FDA method that was established in 1987 to set an endotoxin limit for products intended for parenteral use. This would then be followed by both the USP and EP. Thereby a draft for the Method to set the Endotoxin Limit, which is to be described in the Information chapter of the JP 13 Supplement, is being prepared. This report details an explanation of the draft, the definition of the endotoxin unit (EU) and its defined process, and the compliance with the replacement of the Pyrogen Test by the Bacterial Endotoxins Test, etc.
Ogawa
Y
Y
D004353:Drug Evaluation, Preclinical; D004731:Endotoxins / Q000032:analysis*; D007564:Japan; D010602:Pharmacopoeias as Topic
D004731:Endotoxins