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What is Dmaic HPLC about?

The document outlines the development and validation of a robust RP-HPLC method for an API using the DMAIC approach, adhering to ICH guidelines. It details the phases of the project, including defining the analytical target profile, conducting risk assessments, and establishing a method operable design region. Key achievements include successful validation of the method, establishment of critical method parameters, and identification of risks to enhance analytical performance.

Author

Samer Odeh

Language

EN