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This document provides an overview of USP chapters 661, 1663, and 1664. It discusses definitions related to materials of construction, containers, packaging components, extractables, and leachables. It outlines responsibilities of drug holders and suppliers to ensure compliance. It describes types of testing required by these chapters, including biological reactivity, identification, physicochemical properties, and extractable metals. Factors to consider in extractables and leachable study design like dosag

Author

Md Tayfuzzaman

Language

EN