Nebivolol EP Impurity B (TFA salt)

Development and validation of a stability-indicating reverse phase ultra performance liquid chromatographic method for the estimation of nebivolol impurities in active pharmaceutical ingredients and pharmaceutical formulation
Veera Raghava Raju Thummala, Mohana Krishna Lanka
Se Pu. 2015 Oct;33(10):1051-8.
 
Stability-Indicating RP-UPLC Method Development and Validation for the Process Related Impurities of Nebivolol and Structural Characterization of Its Forced Degradation Products by LC-MS/MS
Prasad Kancherla1* , Pallavi Alegete1 , Srinivas Keesari2 , Bhavyasri Khagga1 , Sridhar Siddiraju3 , Mukkanti Khagga1 and Parthasarathi Das
British Journal of Pharmaceutical Research 14(6): 1-13, 2016
 
Liquid chromatographic impurity profiling of Nebivolol Hydrochloride from bulk drug
Sachin Uttamrao Kokil*1 , Manish Sudesh Bhatia
Scholars Research Library Der Pharma Chemica, 2009, 1(2): 177-187
 
A Sensitive and Selective GC-MS Analysis of Process Related Genotoxic Impurities of Nebivolol Hydrochloride
Vijaya Lakshmi Maddala, K. Venugopal, P.C. Ray, K.M.V.N. Rao

Nebivolol EP Impurity B (TFA salt) is chemically (1RS,1′RS)-2,2′-azanediylbis[1-[(2SR)-6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl]ethan-1-ol] trifluoroacetate. Nebivolol EP Impurity B (TFA salt) is supplied with detailed characterization data compliant with regulatory guideline. Nebivolol EP Impurity B (TFA salt) 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 Nebivolol.

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.