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Synthesis-Related Impurities

Meaning

Synthesis-Related Impurities are unintended chemical components present in an Active Pharmaceutical Ingredient (API) or finished drug product that arise directly from the chemical reactions and processes utilized during the substance’s manufacturing. These impurities include unreacted starting materials, intermediate compounds formed during the synthesis pathway, and unwanted by-products generated by side reactions. Rigorous identification, quantification, and control of these substances are a mandatory part of pharmaceutical quality assurance to ensure the safety, purity, and efficacy of the final medication.