Extractables and Leachables for Pharmaceutical and Medical Packaging

Evaluation of extractables & leachables for pharmaceutical and medical device packaging and containers, including compatibility assessments.

Studies of extractable and leachable components within packaging and closures are required to meet the safety requirements for marketed medicines. Intertek undertakes E/L studies for a wide range of drug products in a variety of packaging types, conducted in accordance with GLP and cGMP requirements.

Extractables and leachables testing for pharmaceutical and medical device packaging:

• Organic and inorganic components
• Develop HPLC, GC, and ICP methods for controlled extractables from pharmaceutical containers, closures and devices
• Identify and profile extractables using GC/MS and LC/MS
• Modify controlled extractable methods for use in routine extractable testing
• Validate routine extractable methods for product and batch release
• Modify controlled extractable methods for testing and profiling of leachables
• Validate leachables methods for incorporation into stability and storage programs

Pharmaceutical Testing Services:

• Pharmaceutical Services
• Extractables and Leachables

Contact us to see how Intertek can help your organization with Extractables and Leachables for Pharmaceutical and Medical Packaging.