Abstract
Olmesartan medoxomil 1 is the latest angiotensin receptor antagonist approved by the FDA for the treatment of hypertension. During the process development of olmesartan medoxomil, four related substances (impurities) were observed along with the final API. Those impurities were identified as olmesartan acid, 4-acetyl olmesartan, 5-acetyl olmesartan, and dehydro olmesartan. Present work describes the synthesis and characterization of all these four impurities.
Highlights
The presence of impurities, called as, related substances in an active pharmaceutical ingredient (API) can have a significant impact on the quality and safety of the drug products
We have described an efficient, industrial scale synthesis of olmesartan medoxomil 1.6 During the synthesis of 1, we came across many process related impurities and some of them were captured in our prior report.[7]
Olmesartan medoxomil 1 was subjected to basic hydrolysis using sodium hydroxide in methanol at ambient reaction conditions afforded the impurity 2 in good yield and 99% HPLC purity
Summary
The presence of impurities, called as, related substances in an active pharmaceutical ingredient (API) can have a significant impact on the quality and safety of the drug products.
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
