The bacterial endotoxins test is required as specification in the raw materials used for parenteral products manufacture and in the parenteral products themselves.
This test is also recommended by the European Pharmacopoeia and the FDA in the cosmetic and food industries for pyrogen detection. Additionally, several medical devices also require this test in order to unsure its safety.
The bacterial endotoxins test is used for detection and quantification of gram negative bacterial endotoxins using the Limulus polyphemus amebocyte lysate.
What is needed for these studies?
For this test it is needed a qualified equipment and validated method according to the Chapter 2.6.14. Bacterial Endotoxins of European Pharmacopoeia as well as the GMP certification.
What Netpharmalab offers to you…
At Netpharmalab we carry out the bacterial endotoxins test using the chromogenic kinetic method described in European Pharmacopoeia, since it is a highly sensible, accurate, quick and robust method.