2.3.S Drug Substance
2.3.S Drug Substance
2.3.S Drug Substance
2.3.S.1 General Information
2.3.S.1 General Information
2.3.S.1 General Information
Information from 3.2.S.1 section of Module 3 should be included here.
Information from 3.2.S.1 section of Module 3 should be included here.
Information from 3.2.S.1 section of Module 3 should be included here.
2.3.S.2 Manufacture
2.3.S.2 Manufacture
2.3.S.2 Manufacture
2.3.S.3 Characterization
2.3.S.3 Characterization
2.3.S.3 Characterization
2.3.S.4 Control of Drug Substance
2.3.S.4 Control of Drug Substance
2.3.S.4 Control of Drug Substance
A brief summary of the justification of the specifications, the analytical procedures, and validation should be included. Specification from 3.2.S.4.1 of Module 3 should be imported directly. A tabulated summary of the batch analyses from 3.2.S.4.4, with graphic representation where appropriate, should be imported directly.
A brief summary of the justification of the specifications, the analytical procedures, and validation should be included. Specification from 3.2.S.4.1 of Module 3 should be imported directly. A tabulated summary of the batch analyses from 3.2.S.4.4, with graphic representation where appropriate, should be imported directly.
A brief summary of the justification of the specifications, the analytical procedures, and validation should be included. Specification from 3.2.S.4.1 of Module 3 should be imported directly. A tabulated summary of the batch analyses from 3.2.S.4.4, with graphic representation where appropriate, should be imported directly.
2.3.S.5 Reference Standards or Materials
2.3.S.5 Reference Standards or Materials
2.3.S.5 Reference Standards or Materials
2.3.S.6 Container Closure System
2.3.S.6 Container Closure System
2.3.S.6 Container Closure System
2.3.S.7 Stability
2.3.S.7 Stability
2.3.S.7 Stability
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