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  • chevymalibu1966 chevymalibu1966 Sep 23, 2003 8:34 AM Flag

    What is CMC?

    and the whole synthesis in how to make it from step one to step x. Includes reagents, times, temperatures, analytical controls, yields, quality, final product testing, etc... even before formulation is started. Tell the FDA or ICH how it's made in great detail.

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