HOW TO SPEED UP EXTRACTABLE AND LEACHABLE TESTING TO ACHIEVE QUALITY BY DESIGN

摘要

Extractable and leachable testing is a complex and challenging requirement for OINDPs. The presentation covers some novel approaches to extractable and leachable testing that either dramatically reduces analysis time or improves number of samples that can be analysed. This reduced time and/or high sample throughput enables a quality by design approach for extractables and leachables. Particular areas of focus will be fast analysis of both volatile and semi volatile leachables from the same pMDI, whilst still enabling additional testing to be carried out on the same canister.