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八月 20, 2021

Extractables and Leachables – A Roadmap

In view of patient safety and product quality, extractables and leachables assessments of pharmaceutical packaging and delivery systems have become an integral part of both development and regulatory submissions. Two crucial USP guidance chapters, USP <1663> “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and USP <1664> “Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems” have been published to guide pharmaceutical companies on the practical and technical considerations required for extractables and leachables assessment programs.

Eric Tan

Sr. Specialist, SA, Jurong

以前的博客
Elastomers

五月 21, 2019

West Presents on Extractables and Leachables in China

Candice Sun

Candice Sun

Junior Specialist, Scientific Affairs, China

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