BIOMAT Database Logo BIOMAT Database Logo

Isolation and characterization of novel process-related impurities in empagliflozin. 2021

Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Key Laboratory of Chemical Biology and Traditional Chinese Medicine (Ministry of Educational of China), Key Laboratory of Phytochemistry R&D of Hunan Province, and Key Laboratory of the Assembly and Application of Organic Functional Molecules of Hunan Province, College of Chemistry and Chemical Engineering, Hunan Normal University, Changsha, Hunan, 410081, China.

Empagliflozin is an effective sodium glucose cotransporter-2 (SGLT2) inhibitor to improve glycemic control in adults with type 2 diabetes. During the manufacture of empagliflozin, three unknown impurities were discovered in pilot batches ranging from 0.05 % to 0.15 % by LC analysis. These unknown impurities were isolated from the crystallization mother liquor by column chromatography and semi-preparative LC, and their structures were elucidated by comprehensive analysis of HRMS, 1D-NMR (1H, 13C) and 2D-NMR (1H-1H COSY, HSQC, HMBC) spectroscopy data. The plausible mechanistic pathways to the formation of these three impurities were also discussed.

UI MeSH Term Description Entries
D009682 Magnetic Resonance Spectroscopy Spectroscopic method of measuring the magnetic moment of elementary particles such as atomic nuclei, protons or electrons. It is employed in clinical applications such as NMR Tomography (MAGNETIC RESONANCE IMAGING). In Vivo NMR Spectroscopy,MR Spectroscopy,Magnetic Resonance,NMR Spectroscopy,NMR Spectroscopy, In Vivo,Nuclear Magnetic Resonance,Spectroscopy, Magnetic Resonance,Spectroscopy, NMR,Spectroscopy, Nuclear Magnetic Resonance,Magnetic Resonance Spectroscopies,Magnetic Resonance, Nuclear,NMR Spectroscopies,Resonance Spectroscopy, Magnetic,Resonance, Magnetic,Resonance, Nuclear Magnetic,Spectroscopies, NMR,Spectroscopy, MR
D002851 Chromatography, High Pressure Liquid Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed. Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D003924 Diabetes Mellitus, Type 2 A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY. Diabetes Mellitus, Adult-Onset,Diabetes Mellitus, Ketosis-Resistant,Diabetes Mellitus, Maturity-Onset,Diabetes Mellitus, Non-Insulin-Dependent,Diabetes Mellitus, Slow-Onset,Diabetes Mellitus, Stable,MODY,Maturity-Onset Diabetes Mellitus,NIDDM,Diabetes Mellitus, Non Insulin Dependent,Diabetes Mellitus, Noninsulin Dependent,Diabetes Mellitus, Noninsulin-Dependent,Diabetes Mellitus, Type II,Maturity-Onset Diabetes,Noninsulin-Dependent Diabetes Mellitus,Type 2 Diabetes,Type 2 Diabetes Mellitus,Adult-Onset Diabetes Mellitus,Diabetes Mellitus, Adult Onset,Diabetes Mellitus, Ketosis Resistant,Diabetes Mellitus, Maturity Onset,Diabetes Mellitus, Slow Onset,Diabetes, Maturity-Onset,Diabetes, Type 2,Ketosis-Resistant Diabetes Mellitus,Maturity Onset Diabetes,Maturity Onset Diabetes Mellitus,Non-Insulin-Dependent Diabetes Mellitus,Noninsulin Dependent Diabetes Mellitus,Slow-Onset Diabetes Mellitus,Stable Diabetes Mellitus
D004340 Drug Contamination The presence of organisms, or any foreign material that makes a drug preparation impure. Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
D005960 Glucosides A GLYCOSIDE that is derived from GLUCOSE. Glucoside
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001559 Benzhydryl Compounds Compounds which contain the methyl radical substituted with two benzene rings. Permitted are any substituents, but ring fusion to any of the benzene rings is not allowed. Diphenylmethyl Compounds,Compounds, Benzhydryl,Compounds, Diphenylmethyl

Related Publications

Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Isolation, identification and characterization of novel process-related impurities in flupirtine maleate.
March 2014, Journal of pharmaceutical and biomedical analysis,
Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Isolation and characterization of process-related impurities in linezolid.
October 2002, Journal of pharmaceutical and biomedical analysis,
Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Identification, isolation and characterization of process related impurities in ezetimibe.
January 2014, Journal of pharmaceutical and biomedical analysis,
Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Identification, isolation and characterization of process-related impurities in Rizatriptan benzoate.
January 2009, Journal of pharmaceutical and biomedical analysis,
Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Isolation and characterization of process-related impurities and degradation products in larotaxel.
July 2011, Journal of pharmaceutical and biomedical analysis,
Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Isolation and characterisation of process-related impurities in rofecoxib.
June 2002, Journal of pharmaceutical and biomedical analysis,
Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Isolation, identification and structure elucidation of two novel process-related impurities of retigabine.
October 2014, Journal of pharmaceutical and biomedical analysis,
Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Isolation, identification, characterization, synthesis and quality control strategy of new process-related impurities in ambrisentan.
February 2019, Journal of pharmaceutical and biomedical analysis,
Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Isolation and characterization of process related impurities of olanzapine using HPLC and ESI-MS/MS.
January 2008, Journal of separation science,
Yanqing Chen, and Huiliang Li, and Hang Hong, and Hongwen Tao, and Xianglin Peng, and Guangyu Xu
Isolation and characterization of degradation products of citalopram and process-related impurities using RP-HPLC.
June 2008, Journal of separation science,
Copied contents to your clipboard!