The newest USP chapter on endotoxin testing fills in the regulatory gaps that have resulted following the withdrawal of the 1987 FDA Guideline and implementation of its replacement Q&A. In this webinar, we analyze the most important points introduced by this guideline and their potential impact on our daily lab work. Join us as we discuss:
- Preparatory requirements on RSE/CSE, consumables, analyst qualification, calibration, and the laboratory environment
- Method suitability for endotoxin limits, MVD, suitability testing, and common test interferences
- Routine testing for sampling, pooling, out of specification results, and retesting considerations and standard curve control
- Alternate test methods
Technical Service Specialist, Charles River
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