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Page 168 of 305 CHAPTER 4 Method Development and validation for related substances of Omeprazole in API and formulations by uplc . Introduction Omeprazole Formula : C17H19N3O3S CAS Number : 73590-58-6 Molecular Weight : Synonyms : 1H-Benzimidazole,5-methoxy-2-[[(4-methox y- 3,5-dimethyl- 2- pyridinyl)methyl]sulfinyl]; 5-Methoxy-2-(((4-methoxy- 3,5- dimethyl- 2-pyridyl)methyl)sulfinyl)benzimidazole; 2- (((3,5-Dimethyl-4- methoxy-2-pyridyl)methyl)sulfinyl)-5- methoxy- 1H-benzimidazole Melting point : 156 C Omeprazole having chemical nomenclature of (RS)-5-methoxy-2-((4-methoxy-3,5-dimethy lpyridin-2-yl) methylsulfinyl)-1H-benzo[d]imidazole belongs to a of class molecule called as proton pump inhibitors. Omeprazole was first approved in Sweden in 1988 for treatment of duodenal ulcer. It was approved in Canada and in the United States in 1989, for treatment of duodenal ulcer, gastric ulcers, reflux esophagitis, and Zollinger-Ellison syndrome1.
Page 168 of 305 CHAPTER 4 Method Development and validation for related substances of Omeprazole in API and formulations by UPLC. Introduction
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