Tetrabenazine Impurity 28

Structural elucidation of two photolytic degradation products of tetrabenazine
Zouaoui Bourezg, Nathalie Cartiser, Laurent Ettouati, Jean Guillon, Aline Lacoudre, Noël Pinaud, Marc Le Borgne, Hatem Fessi
Journal of Pharmaceutical and Biomedical Analysis Volume 91, 25 March 2014, Pages 138-143
 
Behaviour of Tetrabenazine in Acid Medium: Reassessment and Impact on Formulation
Laurent Ettouati, Zoé Senta-Loys, Sandrine Bourgeois, Bernard Fenet, Marc Le Borgne and Hatem Fessi
Pharmaceutics 2019, 11(1), 44
 
Absolute configuration of (+)‐α‐dihydrotetrabenazine, an active metabolite of tetrabenazine
Michael R. Kilbourn  Lihsueh C. Lee  Mary J. Heeg  Douglas M. Jewett
Chirality Volume9, Issue1 1997 Pages 59-62
 
An Applicable Method for the Estimation of Tetrabenazine by Simple RP-HPLC in Tablet Dosage Form
Mehdi Rezaei, Ali Ramazani,  Morteza Rouhani
Chemical Methodologies Volume 1, Issue 2 September and October 2017 Pages 136-144

Tetrabenazine Impurity 28 is chemically 3-(2-Hydroxy-2-methylpropyl)-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one. Tetrabenazine Impurity 28 is supplied with detailed characterization data compliant with regulatory guideline. Tetrabenazine Impurity 28 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 Tetrabenazine.

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.