Leucine

Leucine Impurities & Reference Standards

Leucine is recognized as an active pharmaceutical ingredient (API) that supports formulation development, process validation, and quality assurance in drug manufacturing. Leucine is registered under CAS Number 61-90-5. With molecular formula C6H13NO2 and molecular weight 131.2 g/mol, its physicochemical identity is well characterized. High-purity Leucine and its related substances / process impurities are essential for analytical method development, method validation, quality control, and regulatory submissions under ICH, USP, BP, and EP guidelines. Leucine is available as a certified impurity reference standard with CoA, HPLC chromatograms, and spectroscopic data to support analytical method development and regulatory compliance.