Ezetimibe Impurity 16

Related substances by HPLC method for the detection and evaluation of impurities in ezetimibe drug material
By Rapeti, Durgababu; Reddy, Gudibanda Chandra Sekhar; Narayanarao, Kapavarapu Maruthi Venkata; Shyamala, Pulipaka; Krishna, Rallabhandi Murali
From International Journal of Pharmaceutical Sciences and Research (2021), 12(1), 217-225
 
Stability-​indicating liquid chromatographic method for the simultaneous determination of rosuvastatin and ezetimibe from pharmaceuticals and biological samples
By Kurbanoglu, Sevinc; Esim, Ozgur; Ozkan, Cansel Kose; Savaser, Ayhan; Ozkan, Yalcin; Uslu, Bengi; Ozkan, Sibel A.
From Journal of the Turkish Chemical Society, Section A: Chemistry (2020), 7(3), 865-874
 
Stability-​indicating analytical method development using quality by design approach for simultaneous estimation of ezetimibe and glimepiride
By Shah, U.; Shah, Kunti; Patel, Rupal
From Indian Journal of Pharmaceutical Sciences (2019), 81(2), 273-281
 

Ezetimibe Impurity 16 is chemically (S)-3-((S)-5-(4-Fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one. Ezetimibe Impurity 16 is supplied with detailed characterization data compliant with regulatory guideline. Ezetimibe Impurity 16 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 Ezetimibe.

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.