The assessment of leachables and extractables ( E&L) in pharmaceutical products and food are important in drug product development and food production to meet safety requirements for marked introduction. Processing equipment, as well as container closures and product packaging are potential sources for chemical contaminants.
Additives such as antioxidants, plasticisers, stabilizers, dyes, metal catalysts and other harmful chemicals may potentially migrate into the product under storage conditions. Vitas provide a service for testing extractables in container materials and leachable. These tests can also be performed in cGMP compliant laboratories using technologies that detect ultra-trace levels.
Our extractables and leachables analytical services include:
• Develop HPLC, GC, and MS methods for controlled extractables from pharmaceutical containers, closures and devices
• Identify and profile extractables using GC/MS and LC/MS techniques.
• 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
Contact us for further discussions on how Vitas can help your organization with Extractables and Leachables services.
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