Wish list (0)Starting Material Impurity Reference Standards
This classification focuses on the impurities introduced into starting materials at the source of drug synthesis. As the starting point of the drug impurity profile, impurities in starting materials (such as synthesis by-products, isomers, residual reagents, etc.) may enter the final product through the reaction pathway, directly affecting the quality of the active pharmaceutical ingredient. We provide various specific impurity reference standards for starting materials, covering known impurities with confirmed structures and potentially genotoxic impurities. Our products strictly follow guidelines such as ICH M7, and are accompanied by complete analytical data (NMR, LC-MS, etc.), helping you establish effective quality control strategies from the source, realizing the R&D concept of "quality by design", and ensuring compliance with drug registration and production regulations.
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