Darifenacin Pyrrolidine Impurity Racemate

Identification, isolation and characterization of dimer impurities in antimuscarinic agent darifenacin hydrobromide
By Gupta, P. Badarinadh; Rao, B. Venkateswara; Douglas, S. Paul; Sharma, Hemant Kumar; Bharathi, D. Vijaya
From World Journal of Pharmaceutical Research (2017), 6(6), 1041-1063
 

Development and validation of HPLC method for determination of potential genotoxic impurities in darifenacin hydrobromide drug substance
By Patcha, Vinay Kumar; Gajbhiye, Susheela Bhai; Vundavilli, Jagadeesh Kumar; Kothapalli, S. R. Pavan Kumar; Sreenivas, N.; Ray, U. K.
From International Journal of Pharmacy and Pharmaceutical Research (2017), 8(2), 198-208

Development and validation of a stability-​indicating RP-​HPLC method for determination of darifenacin hydrobromide in bulk drugs
By Nazeerunnisa, Mohammed; Garikapati, Lakshmi; Bethanabhatla, Syama Sundar
From American Journal of Analytical Chemistry (2014), 5(17), 1239-1248
 

Darifenacin Pyrrolidine Impurity Racemate is chemically 2-(3-Pyrrolidinyl)-2,2-diphenylacetamide ; 2,2-Diphenyl-2-(pyrrolidine-3-yl)acetamide. It is also known as Darifenacin Amide Impurity. Darifenacin Pyrrolidine Impurity Racemate is supplied with detailed characterization data compliant with regulatory guideline. Darifenacin Pyrrolidine Impurity Racemate 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 Darifenacin.

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.