Bisoprolol EP Impurity G

High-performance liquid chromatographic method for the determination of bisoprolol and potential impurities
Nelly N. Agapova*,Elissaveta Vasileva
Journal of Chromatogrkphy A, 654 (1993) 299-352
 
Investigation of the retention mechanisms of amlodipine besylate, bisoprolol fumarate, and their impurities on three different HILIC columns
Irena Kasagić-Vujanović, Biljana Jančić-Stojanović & Darko Ivanović
Journal of liquid chromatography & related technologies 2018, vol. 41, no. 9, 523–531
 
Robust UHPLC Separation Method Development for Multi‑API Product Containing Amlodipine and Bisoprolol: The Impact of Column Selection
Róbert Kormány, Imre Molnár, Jenő Fekete, Davy Guillarme & Szabolcs Fekete
Chromatographia volume 77, pages1119–1127(2014)
 
Stability-Indicating RP-HPLC and CE Methods for Simultaneous Determination of Bisoprolol and Perindopril in Pharmaceutical Formulation: A Comparative Study
Said A. Hassan, Nancy W. Nashat *, Mohamed R. Elghobashy, Samah S. Abbas and Azza A. Moustafa
Journal of Chromatographic Science, Volume 58, Issue 8, September 2020, Pages 747–758

Bisoprolol EP Impurity G is chemically (2RS)-1-[4-[[(2-isopropoxyethoxy)methoxy]methyl]phenoxy]-3-isopropylaminopropan-2-ol fumarate (2:1) (as per EP) ; (1-(4-{[(2-Isopropoxyethoxy)methoxy]methyl}phenoxy)-3-(isopropylamino)propan-2-ol fumarate (2:1) salt (as per USP). It is also known as Bisoprolol USP Related Compound D. Bisoprolol EP Impurity G is supplied with detailed characterization data compliant with regulatory guideline. Bisoprolol EP Impurity G 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 Bisoprolol.

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.