According to Ph Eur 2.6.8 and USP <151>, the pyrogen test is the classic method for testing sterile pharmaceuticals for contamination with pyrogens. In many cases, it has now been replaced by the Limulus Amebocyte Lysate test (LAL test). However, there is a wide variety of products for which the pyrogen test, which cannot yet be safely replaced by any other method, is compulsory and required. This is especially the case where products from blood components need to be examined and where the LAL test does not provide sufficiently meaningful results.
For further information and questions, we are happy to answer your questions at +49 (0)9708/9100-280.
Press release dated 23 April 2018
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