Understanding and setting endotoxin limits
Weary, M.E.
Journal of Parenteral Science and Technology a Publication of the Parenteral Drug Association 44(1): 16-18
1990
ISSN/ISBN: 0279-7976 PMID: 2313486 Document Number: 3598
From time to time, biotechnology and other parenteral drug companies must validate LAL pyrogen tests for raw materials or new drug entities. Since there usually are no established endotoxin limits for these items, quality control personnel must be prepared to determine, and defend, pass/fail LAL pyrogen test limits for these articles. An explanation of the FDA/USP approach to setting endotoxin limits is given, and suggestions are made for devising appropriate in-house LAL test limits for new drug raw materials and finished products.
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