Microbiology In-Depth Focus 2018
In this In-Depth Focus; specificity in the recombinant factor C test for endotoxin, the latest trends in pharmaceutical microbiology, and the changing environment in pyrogen and endotoxin testing.
- Specificity in the recombinant factor C test for endotoxin
Limulus amebocyte lysate (LAL) users, compendial experts and regulators are still orienting themselves to the recombinant factor C (rFC) assay. Changes to compendial standards do not occur overnight and, for now, users willing to change must perform the alternative validation procedure USP <1225>.
- The latest trends in pharmaceutical microbiology
There have been many changes in pharmaceutical microbiology as we progressed into the 21st century. Some of these changes have been due to the advance of rapid microbiological methods and knowledge gained from the study of the human microbiome, while others are changes to conventional testing methods. This paper discusses some of the recent changes in areas of interest to microbiologists.
- The changing environment in pyrogen and endotoxin testing
Pyrogen testing of drug products for parenteral administration is a mandatory task. Regulatory authorities require that each batch of drug product is pyrogen-free. Historically, the rabbit pyrogen test (RPT) was the required test but in most cases can be replaced by the endotoxin specific Limulus Amebocyte Lysate (LAL) test.
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