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Abstract

FUNDAMENTALS OF ANALYTICAL METHOD DEVELOPMENT

Siddhi Sartape*, Gauri Patil, Rajendra Patil

ABSTRACT

Pharmaceutical discovery, development, and manufacturing all heavily rely on the development and validation of analytical methods. The process of demonstrating that an analytical method is suitable for measuring the concentration of an active pharmaceutical ingredient in a particular compounded dosage form is known as method development. This process enables the use of simplified procedures to confirm that an analytical procedure will reliably and accurately produce a measurement of an active ingredient in a compounded dosage form.

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