Biotin

Biotin Impurities & Reference Standards

Biotin is recognized as an active pharmaceutical ingredient (API) that supports formulation development, process validation, and quality assurance in drug manufacturing. Biotin is registered under CAS Number 58-85-5. With molecular formula C10H16N2O3S and molecular weight 244.3 g/mol, its physicochemical identity is well characterized. Biotin impurity reference standards are used to support assay development, purity testing, and stability studies in line with global pharmacopoeial requirements (ICH, USP, BP, EP). We supply certified Biotin reference standards and impurity markers with complete documentation, including a Certificate of Analysis (CoA), HPLC chromatograms, and spectroscopic data, for pharmaceutical research, manufacturing, and regulatory use.