Tolbutamide

Tolbutamide Impurities & Reference Standards

Tolbutamide is an established active pharmaceutical ingredient (API) with broad application in pharmaceutical formulation, drug substance manufacturing, and quality control. Tolbutamide is registered under CAS Number 64-77-7. With molecular formula C12H18N2O3S and molecular weight 270.3 g/mol, its physicochemical identity is well characterized. Tolbutamide related substances / impurity reference standards support HPLC method validation, forced degradation studies, and regulatory documentation consistent with ICH, USP, BP, and EP requirements. Each batch of Tolbutamide reference standard is accompanied by a Certificate of Analysis (CoA), HPLC purity data, and spectroscopic (NMR/MS/IR) characterization for use in pharmaceutical laboratories worldwide.