Endotoxins are toxins of a lipopolysaccharide (LPS) and heat-stable nature, located in the outer membrane of certain Gram-negative (Gram-) bacteria. ACM PHARMA provides you with sensitive and specific methods for measuring bacterial endotoxins in raw materials, finished, semi-finished and intermediate products and process water.
The bacterial endotoxins tests are conducted in accordance to the reference standards in force:
Method D kinetic colorimetry according to Eur Ph, chap 2.6.14, USP <85> and <161>
Endozyme method (rFc) according to Eur Ph, chap 2.6.32
(Cofrac) tests covered by the field of COFRAC accreditation (ISO 17025) - scope available on www.cofrac.fr.
The issue of a test report bearing the mark COFRAC is subject to conditions: the test must be carried out in accordance to the conditions laid down in the reference table, in particular when the reference table requires the prior validation of operating conditions.