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A study on structural characterization of potential impurities of Sugammadex sodium using LC/ESI/QTOF/MS/MS and NMR
Senthil Kumar Pichandi Mohanraj1, Ramachar Tulasi2, Venkatesan Chidambaram Subramanian3
1Department of Chemistry, Jawaharlal Nehru Technological University, Anantapur 515002, Andhra Pradesh, India,; Gland Pharma Ltd, Research and Development, D.P. Pally, Hyderabad 500043, Telangana, India.
Abstract:
The first selective relaxant binding agent (SRBA), Sugammadex sodium (SGS) is used to reverse anesthesia. A study of the process related and degradation products will help to optimize process parameters and also to develop the analytical methods and set the quality standard for a quality control strategy in pharmaceutical industry. During the manufacture of SGS, all the process related impurities are controlled in every stage and process related and degradation products are controlled in the active pharmaceutical ingredient (API) as per ICH guidelines. A total of nine process related and degradation impurities of SGS (Impurity-A to Impurity-I) were isolated and characterized by using LC/ESI/QTOF/MS/MS and NMR studies.
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