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Where can drug manufacturers find information regarding endotoxin testing?

19/09/2021 | 3198

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Reply:

USP publishes endotoxin testing recommendations and acceptance criteria in USP General Chapter <85> Bacterial Endotoxins Test. General Chapter <85> provides methods and calculation of limits for drugs. FDA may, as needed, provide additional guidance to clarify the Agency’s current thinking on use of Limulus Amebocyte Lysate (LAL), recombinant LAL, and other endotoxin testing methods.

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