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Johannes Reich

 

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The changing environment in pyrogen and endotoxin testing

Pyrogen testing of drug products for parenteral administration is a…

26 April 2018 | By , ,

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 specifi c Limulus Amebocyte Lysate (LAL) test.