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Chapter-2 Analytical Method Development and …

Chapter-2 . Analytical Method Development and validation Overview The primary focus of this chapter is on general approaches and considerations toward Development of chromatographic methods for separation, identification, and quantification of pharmaceutical compounds, which may be applied within the various functions in the drug Development continuum. The chapter also discusses the issues and parameters that must be considered in the validation of Analytical methods . At the end of the chapter , a scope of the present research study is covered. GENERAL INTRODUCTION. The number of drugs introduced into the market is increasing every year.

Analytical Method Development and Validation 58 drug product impurities may also be available. These public standards and literature data play a

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