Empagliflozin Acetyl impurity

Stability indicating HPLC-​Fluorescence detection method for the simultaneous determination of linagliptin and empagliflozin in their combined pharmaceutical preparation
By Rizk, Mohamed; Attia, Ali Kamal; Mohamed, Heba Yosry; Elshahed, Mona
From European Journal of Chemistry (2021), 12(2), 168-178
 
Stability indicating hplc method for the quantification of (R)​-​Isomer in empagliflozin drug substance
By Korlakunta, Vijaya Gouri; Sreenivas, N.; Sharma, Hemant Kumar; Nowduri, Annapurna; Bonige, Kishore Babu; Chavakula, Ramadas
From European Journal of Biomedical and Pharmaceutical Sciences (2021), 8(4), 177-184.

Simultaneous determination, validation and forced degradation studies of metformin and empagliflozin using new HPLC analytical method
By Riaz, Muhammad Kashif; Niaz, Sultan; Asghar, Muhammad Arif; Shafiq, Yousra; Zehravi, Mehrukh; Shah, Syed Suffdar Hussain; Abdul Rehman, Ahad; Khan, Kamran
From Latin American Journal of Pharmacy (2020), 39(11), 2257-2265.

Empagliflozin Acetyl impurity is chemically (2R,3R,4R,5S,6S)-2-(Acetoxymethyl)-6-(4-chloro-3-(4-hydroxybenzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate. Empagliflozin Acetyl impurity is supplied with detailed characterization data compliant with regulatory guideline. Empagliflozin Acetyl impurity 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 Empagliflozin.

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.