Teriflunomide Impurity 31

Quality-by-design-based development and validation of a stability-indicating UPLC method for quantification of teriflunomide in the presence of degradation products and its application to in-vitro dissolution
Nukendra Prasad Nadella,Venkata Nadh Ratnakaram & N. Srinivasu
Journal of Liquid Chromatography & Related Technologies Volume 40, 2017 - Issue 10 Pages 517-527
 
Development of Validated Stability Indicating HPTLC Method for the Estimation of Teriflunomide in Bulk and Tablet Dosage Form
Karmankar, Snehal; Tajne, M.
Current Pharmaceutical Analysis, Volume 16, Number 7, 2020, pp. 814-822(9)
 

Teriflunomide Impurity 31 is chemically 1,1'-(Methylenebis(4,1-phenylene))bis(3-(3-(trifluoromethyl)phenyl)urea). Teriflunomide Impurity 31 is supplied with detailed characterization data compliant with regulatory guideline. Teriflunomide Impurity 31 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 Teriflunomide.

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.