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Esomeprazole Magnesium Validation Report
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상세내용은 첨부파일 참조바랍니다.
1. Executive Summary
a. Goals: The reference procedure described herein was developed for the MC monograph for Esomeprazole
Magnesium.
b. Background
i. Esomeprazole Magnesium is a proton pump inhibitor and used in the treatment of dyspepsia, pepticulser
disease, gastroesophageal reflux disease and other conditions caused by excess stomach acid.
ii. The active moiety of the medicine is Esomeprazole, and all dosing information is based on the free base.
iii. The drug is available as tablets, capsules and oral suspension.
iv. Quality monographs in USP, EP and BP are available.
v. The molecular formula is C34H36MgN6O6S2 · 3H2O and the molecular weight is 767.17.
c. The Reference procedure is based upon the USP-MC procedure for Esomeprazole Sodium.
- esomeprazole magnesium_validation report.pdf (1.2MB) (0)
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