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The color of active pharmaceutical ingredients (APIs) can be a critical quality attribute for pharmaceutical products. Color variation can be indicative of contaminants, chemical impurities, solid-state form impurities, or degradation products. The color of the pharmaceutical materials is typically specified and determined using visual appearance testing. To avoid the inherent subjectivity of visual appearance testing, to understand the link between the color and the process parameters, and to facilitate quality agreements between customers and vendors of chemical starting materials, quantitative color measurements utilizing visible spectroscopic methods are increasingly needed. In this work, a systematic method development strategy (MDS) is described to assist with the development of robust and rugged quantitative color measurement methods based on a science-and risk-based approach aligned with quality-bydesign principles. The MDS is illustrated using typical scenarios encountered in method development through several examples including a method developed for 2,3-dimethyl-2H-indazol-6-amine, a starting material in the commercial synthesis of pazopanib hydrochloride API.Flowcharts and examples are presented to illuminate key decision points in the MDS process including selection of (1) solution-state versus solid-state spectroscopic method, (2) optimal color space for reporting color measurement results, and (3) appropriate method risk assessment and control to ensure successful method implementation.General guidance is also provided to facilitate the discussion for setting quantitative color specifications.

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