Ketoconazole

Ketoconazole Impurities & Reference Standards

Ketoconazole is a high-purity active pharmaceutical ingredient (API) used in the formulation and manufacture of pharmaceutical products. Ketoconazole is registered under CAS Number 65277-42-1. With molecular formula C26H28Cl2N4O4 and molecular weight 531.4 g/mol, its physicochemical identity is well characterized. Ketoconazole related substances / impurity reference standards support HPLC method validation, forced degradation studies, and regulatory documentation consistent with ICH, USP, BP, and EP requirements. We offer Ketoconazole and its impurity standards with complete analytical documentation, including CoA and HPLC data, suitable for pharmaceutical quality control and regulatory submissions.