Finasteride EP Impurity A

Mechanism-Based Inhibition of Human Steroid 5R-Reductase by Finasteride: Enzyme-Catalyzed Formation of NADP-Dihydrofinasteride, a Potent Bisubstrate Analog Inhibitor
Herbert G. Bull,* Margarita Garcia-Calvo, Stefan Andersson,† Walter F. Baginsky, H. Karen Chan,‡ Dina E. Ellsworth,§ Randall R. Miller, Ralph A. Stearns, Raman K. Bakshi, Gary H. Rasmusson, Richard L. Tolman, Robert W. Myers, John W. Kozarich, and Georgianna S. Harris
J. Am. Chem. Soc. 1996, 118, 2359-2365
 
A systematic study of determination and validation of finasteride impurities using liquid chromatography
Aysen KurtCucuaSerapSakaryabHulya DemircanDemiraSarfrazAhmad
Arabian Journal of Chemistry Volume 13, Issue 2, February 2020, Pages 3783-3789
 
A Stability Indicating UPLC Method for Finasteride and Its Related Impurities
Y. Koti Reddy^1,3, G. V. Subba Reddy², K. N. Jaya Veera³, Kishore Kumar Hotha
American Journal of Analytical Chemistry Vol.3 No.11(2012), Article ID:24469,9 pages
 
Matrix Effect in Quantitative LC/MS/MS Analyses of Biological Fluids: A Method for Determination of Finasteride in Human Plasma at Picogram Per Milliliter Concentrations
B. K. Matuszewski,* M. L. Constanzer, and C. M. Chavez-Eng
Anal. Chem. 1998, 70, 882-889
 
High-performance liquid chromatographic determination of finasteride in human plasma using direct injection with column switching
Terukazu Takano*, Shunsuke Hata
Journal of Chromatography B, 676 (1996) 141-146

 

Finasteride EP Impurity A is chemically (5α,17β)-N-(1,1-Dimethylethyl)-3-oxo-4-aza-androstane-17-carboxamide ; 1,2-Dihydro Finasteride ; . It is also known as Finasteride EP Impurity A ; Finasteride Dihydro Impurity ; 1,2-Dihydro Finasteride Impurity ; . Finasteride EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Finasteride EP Impurity A 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 Finasteride.

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.