Amiodarone

Amiodarone Impurities & Reference Standards

Amiodarone is a high-purity active pharmaceutical ingredient (API) used in the formulation and manufacture of pharmaceutical products. With molecular formula C25H29I2NO3 and molecular weight 645.31 g/mol, its physicochemical identity is well characterized. Amiodarone related substances / impurity reference standards support HPLC method validation, forced degradation studies, and regulatory documentation consistent with ICH, USP, BP, and EP requirements. Our Amiodarone reference standards are provided with full documentation — Certificate of Analysis (CoA), HPLC chromatographic data, and spectral characterization — to support pharmaceutical R&D and GMP manufacturing.