Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms

Introduction .............................................................................................................. 32 Method Development and Its Importance ........................................................... 32

Method Development ...............................................................................................34 API Test Methods ................................................................................................ 35 In-Process Test Methods ..................................................................................... 37 Finished Dosage Form Test Methods .................................................................. 37

Method Validation ....................................................................................................40 Objectives of Method Validation .........................................................................40 Method Validation Requirements ........................................................................40