Celecoxib EP Impurity B

Development of a Unified Reversed-Phase HPLC Method for Efficient Determination of EP and USP Process-Related Impurities in Celecoxib Using Analytical Quality by Design Principles
Tim Tome, Zdenko Časar ,OrcID andAleš Obreza
Molecules 2020, 25(4), 809
 
A selective and sensitive LC-MS/MS method for the simultaneous determination of twopotential genotoxic impurities in celecoxib
Ambavaram Vijaya Bhaskar Reddy, Nandigam Venugopal & Gajulapalle Madhavi
Journal of Analytical Science and Technology volume 5, Article number: 18 (2014)
 
Stability-Indicating HPLC Method for Quantification of Celecoxib and Diacerein Along With Its Impurities in Capsule Dosage Form
Hanimi Reddy Bapatu, Ravi Kumar Maram, R. Satyanarayana Murthy
Journal of Chromatographic Science, Volume 53, Issue 1, January 2015, Pages 144–153

Celecoxib EP Impurity B is chemically 4-[3-(4-Methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide (as per EP) ; 4-[3-(4-methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide (as per USP). It is also known as Celecoxib USP Related Compound B . Celecoxib EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Celecoxib EP Impurity B 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 Celecoxib.

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.