Cevimeline trans-Isomer (USP)

Structural characterization of cevimeline and its trans-impurity by single crystal XRD
Dmitrijs Stepanovs a,b, Zenta Tetere b, Irisa Ravin ¸ a b, Viktors Kumpin¸ sˇ b, Daina Zicane b, Erika Bizdena b, Janis  Bogans c, Irina Novosjolova b, Agnese Grigalovicaˇ b, Remo Merijs Meri b, Juris Fotins d, Maksims Cerkasovs ˇ d, Anatoly Mishneva,b, Maris ¯ Turks
Journal of Pharmaceutical and Biomedical Analysis 118 (2016) 404–409

Cevimeline trans-Isomer (USP) is chemically ((2RS,2'SR)-2'-Methyl-4-azaspiro{bicyclo[2.2.2]octane-2,5'-[1,3]oxathiolane} hydrochloride (as per USP). Cevimeline trans-Isomer (USP) is supplied with detailed characterization data compliant with regulatory guideline. Cevimeline trans-Isomer (USP) 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 Cevimeline.

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.