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3.2.S Drug Substance

Contains the following sections (in 7 separate documents):

-3.2.S.1 General Information
-3.2.S.2 Manufacture
-3.2.S.3 Characterization
-3.2.S.4 Control of Drug Substance
-3.2.S.5 Reference Standards or Materials
-3.2.S.6 Container Closure System
-3.2.S.7 Stability

*Chemistry, Manufacturing, and Controls

3.2.S Drug Substance