Bicalutamide EP Impurity M

Analytical and semipreparative high performance liquid chromatography enantioseparation of bicalutamide and its chiral impurities on an immobilized polysaccharide-based chiral stationary phase
Daniele Sadutto Rosella Ferretti Leo Zanitti Adriano Casulli Roberto Cirilli
Journal of Chromatography A Volume 1445, 6 May 2016, Pages 166-171
 
Isolation and characterization of process related impurities and degradation products of bicalutamide and development of RP-HPLC method for impurity profile study
R. Nageswara Rao ∗, A. Narasa Raju, R. Narsimha
Journal of Pharmaceutical and Biomedical Analysis 46 (2008) 505–519

Bicalutamide EP Impurity M is chemically (2RS)-3-[(4-Fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanoic acid (as per EP). Bicalutamide EP Impurity M is supplied with detailed characterization data compliant with regulatory guideline. Bicalutamide EP Impurity M 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 Bicalutamide.

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.