Quality-control analytical methods: endotoxins: essential testing for pyrogens in the compounding laboratory, part2
Cooper, J.F.; Chakrabarty, K.; McGuire, J.; Zolner, W.J.; Jones, V.; Hedman, H.
International Journal of Pharmaceutical Compounding 14(6): 493-506
2010
ISSN/ISBN: 1092-4221 PMID: 23965654 Document Number: 642260
Ensuring that the endotoxin burden in sterile preparations is within allowable limits is one of the greatest challenges faced by compounding pharmacists. Today, endotoxin analyses can be performed in the pharmacy with a test kit or accomplished by sending samples to a contract testing laboratory. Both types of screening are discussed in this article, and information that enables compounders to determine the preferred method of endotoxin testing is provided. A brief history of endotoxin testing is presented, and the advantages and disadvantages of pyrogen screening with either an in-house test kit or the services of a contract testing laboratory are explored. Accurate screening for pyrogens ensures that only sterile formulations containing a safe level of endotoxins are dispensed. An essential task in sterile compounding, endotoxin testing safeguards patients against the morbidity and mortality that can result from treatment with a contamination preparation.