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2.3.S Quality Overall Summary - Drug Substance

Contains the following sections (in a single document):

-2.3.S.1 General Information
-2.3.S.2 Manufacture
-2.3.S.3 Characterization
-2.3.S.4 Control of Drug Substance
-2.3.S.5 Reference Standards or Materials
-2.3.S.6 Container Closure System
-2.3.S.7 Stability

*Chemistry, Manufacturing, and Controls

2.3.S Quality Overall Summary - Drug Substance