Understanding and setting endotoxin limits.

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.