Extractable and Leachable Assessment

Extractable and leachable assessment identifies substances migrating from pharmaceutical containers, closures, and processing materials into products potentially causing toxicity or stability compromise. Extraction studies employ worst-case conditions including elevated temperature and long contact times. Characterisation identifies extracted substances assessing toxicological potential. Qualification establishes acceptable levels balancing safety against analytical detection limits.

Primary containers including vials and syringes require comprehensive assessment for parenteral products. Elastomer closures leach zinc oxide, antioxidants, and plasticisers necessitating control. Glass containers migrate elements including boron and sodium under certain conditions. Regulatory submissions provide detailed extractable and leachable characterisation. Packaging material selection requires demonstrating adequate safety profiles.