Ramelteon lsobutyryl impurity

Determination of ramelteon and its related substances by RP-​HPLC
By Zhou, Qin-qin; Zou, Qiao-gen; Qu, Ying; Wei, Ping; Ouyang, Ping-kai
From Shenyang Yaoke Daxue Xuebao (2014), 31(3), 197-201.
 
Stability-​indicating UPLC method for determination of ramelteon and their degradation products in active pharmaceutical ingredients
By Reddy, I. Ugandar; Rao, P. Nageswara; Reddy, V. Ranga; Satyanarayana, K. V. V.
From Journal of Liquid Chromatography & Related Technologies (2012), 35(5), 688-699

Ramelteon lsobutyryl impurity is chemically (S)-N-(2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl)isobutyramide. Ramelteon lsobutyryl impurity is supplied with detailed characterization data compliant with regulatory guideline. Ramelteon lsobutyryl impurity can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Ramelteon.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.