Extractables and Leachables (E&L) Studies in Pharmaceutical Development

A risk-based, scientifically justified approach to E&L assessment that protects patient safety, supports product quality, and stands up to global regulatory review. Pharmaceutical products come into contact with packaging systems, manufacturing equipment, process-contact materials, and delivery devices — and even trace-level compounds migrating from these materials can have meaningful implications for patient safety and product quality. With USP , , and and the draft ICH Q3E guideline shaping expectations, regulators increasingly expect a proactive, lifecycle-oriented approach to E&L.

This…