Cinacalcet Impurity 16

Chiral capillary zone electrophoresis in enantioseparation and analysis of cinacalcet impurities: Use of Quality by Design principles in method development
Benedetta Pasquini a, Serena Orlandini a,∗, Mercedes Villar-Navarro b, Claudia Caprini a, Massimo Del Bubbaa, Michal Dousaˇ c, Alessandro Giuffrida d, Roberto Gotti e, Sandra Furlanetto
Journal of Chromatography A Volume 1568, 21 September 2018, Pages 205-213
 
Development and Validation of a Stability-Indicating RP-UPLC Method for the Estimation of Impurities in Cinacalcet Hydrochloride API and its Formulation
Pingili Sunil reddy, Thummala Veera Raghava Raju , Penmetsa Satyanarayana RAJU , Nadimpalli Sunil Varma 1 , Kondra Sudhakar BABU
Sci. Pharm. 2015, 83(4), 583-598

Cinacalcet Impurity 16 is chemically (R)-N-(1-(Naphthalen-1-yl)ethyl)-3-(2-(trifluoromethyl)phenyl)propan-1-amine ; 3-(2-trifluoromethyl)phenyl)-N-(1-(naphthalene-1-yl) ethyl)propan-1-amine . Cinacalcet Impurity 16 is supplied with detailed characterization data compliant with regulatory guideline. Cinacalcet Impurity 16 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 Cinacalcet.

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.