Detection of bacterial endotoxins in medicinal products, raw materials, input materials and medical devices is performed in accordance with the requirements of the European (Czech) Pharmacopoeia, Article 2.6.14, AANSI AAMI ST72:2019, ISO 11737-3 and the American Pharmacopoeia, Articles ⟨85⟩, ⟨161⟩.
- Gel clot method – limit test (Method A)
- Kinetic turbidimetric method – quantitative test (Method C)
Our services are performed within the accreditation regime according to ČSN EN ISO/IEC 17025.