Structure Elucidation and Mechanistic Study of a New Dimeric Degradant in Ropinirole Hydrochloride Extended-Release Tablets

ConclusionsThe newly occurred unknown degradant in ropinirole extended-release tablets was elucidated as the methylene-bridged 1,3 ′-Dimer of ropinirole. Based on the mechanistic study, 1,3′-Dimer and its isomer (3,3′-Dimer) were both formed by the reaction of ropinirole with residual formaldehyde present or formed in lactose, a main excipient of the formulation.
Source: Pharmaceutical Research - Category: Drugs & Pharmacology Source Type: research