The quality control and quality assurance unit of the department Integrated Production Platforms routinely carries out Endotoxin determinations in Water and process samples as part of our monitoring, process development and production activities. Using the EndoSafe®PTS™ -system and a chromogenic LAL-assay, Endotoxins can be quantified down to 0.05 EU/mL according to the European Pharmacopeia. The assay is carried out in-house in the GMP QC lab and our analytical procedures regarding this assay are checked in interlaboratory tests.
Endotoxin determinations can be carried out for third parties. For details of sample preparation, transfer and pricing, please contact us.