July 16, 2025
A new chapter in Quality Control – how USP Chapter <86> can transform approaches to endotoxin testing
Could 2025 be the year that endotoxin testing finally catches up with the 21st century? Unlike other areas of Pharmaceutical Quality Control where innovations such as data analytics and automation have driven extensive modernization, endotoxin testing has remained resolutely stuck in the past. This vital Quality Control procedure has until recently relied on outdated testing practices that require the blood of horseshoe crabs. Significantly, new authoritative standards have recently recognized alternative testing methods that can deliver the same important validation, without relying on animal-derived products.
What are these new standards and what could their integration mean for the future of endotoxin testing?
