Lactitol Monohydrate

Lactitol Monohydrate Impurities & Reference Standards

Lactitol Monohydrate is recognized as an active pharmaceutical ingredient (API) that supports formulation development, process validation, and quality assurance in drug manufacturing. Lactitol Monohydrate is registered under CAS Number 81025-04-9. With molecular formula C12H24O11,H2O and molecular weight 362.3 g/mol, its physicochemical identity is well characterized. Lactitol Monohydrate impurity reference standards are used to support assay development, purity testing, and stability studies in line with global pharmacopoeial requirements (ICH, USP, BP, EP). Lactitol Monohydrate is available as a certified impurity reference standard with CoA, HPLC chromatograms, and spectroscopic data to support analytical method development and regulatory compliance.