Mono Hydroxy Melphalan.HCl

Mono Hydroxy Melphalan.HCl is a hydroxylated derivative of Melphalan, featuring a single hydroxyl substitution on the phenyl ring of the phenylalanine moiety, coupled with a bis(2-chloroethyl)amine group and protonated chloride. This impurity arises via oxidative metabolism or synthetic pathway deviations, introducing a polar hydroxyl functionality that alters physicochemical properties relative to the parent drug. The HCl salt formation stabilizes the compound’s charged amine, enhancing solubility. It serves as an HPLC reference standard for quantifying process-related impurities in Melphalan APIs.