Fenofibrate Impurity 11

Fenofibrate raw materials: HPLC methods for assay and purity and an NMR method for purity
Pauline M. Lacroix a , Brian A. Dawson b,*, Roger W. Sears b , D. Bruce Black b , Terry D. Cyr b , Jean-Claude Ethier
Journal of Pharmaceutical and Biomedical Analysis 18 (1998) 383–402
 
Development of continuous spherical crystallization to prepare fenofibrate agglomerates with impurity complexation using MSMPR crystallizer
Kohei Tahara, Yuichi Kono, Allan S. Myerson, and Hirofumi Takeuchi
Cryst. Growth Des. 2018, 18, 11, 6448–6454
 
Stability indicating UPLC method for simultaneous determination of atorvastatin, fenofibrate and their degradation products in tablets
A.A. Kadav, D.N. Vora
Journal of Pharmaceutical and Biomedical Analysis 48 (2008) 120–126
 
Enhancing the Solubility of Fenofibrate by Nanocrystal Formation and Encapsulation
Raj Kumar1 and Prem Felix Siril
AAPS PharmSciTech volume 19, pages284–292(2018)
 
Validated spectrophotometric determination of Fenofibrate in formulation
Krishna R. Gupta*, Sonali S. Askarkar, Prashant R. Rathod and Sudhir G. Wadodkar
Der Pharmacia Sinica, 2010, 1 (1): 173-178

Fenofibrate Impurity 11 is chemically Isopropyl 2-bromopropanoate. Fenofibrate Impurity 11 is supplied with detailed characterization data compliant with regulatory guideline. Fenofibrate Impurity 11 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 Fenofibrate.

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.