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Testing for Bacterial Endotoxins
Author(s): Jelinek Todd
Issue: Sep/Oct 1998 - Parenteral Nutrition Solutions
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Abstract: Parenteral products must be sterile and endotoxin (pyrogen) free, in addition to having a number of other characteristics and meeting other requirements. In this brief article, the author discusses endotoxin tests, preparation for the test and evaluation of a commercial kit. In summary, endotoxin testing is currently being done by many pharmacists involved in sterile products compounding, especially those doing parenteral nutrition solutions. It is a test that can be easily incorporated into a daily workload, and the tests can be “batched” to minimize the time required per test. This is another quality-control step that is important for the compounding of parenteral products.
Related Categories: PARENTERALS, STERILE PREPARATIONS, SUPPORT, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS