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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., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier B.V. All rights reserved.)

A complete degradation study was performed on cangrelor drug substance as per the ICH guidelines. The study reveals that a total of six degradation products (DP-1 to DP-6) were found and out of these, three unknown degradation products (DP-1, DP-5 and DP-6) were not reported in the literature. Based on the degradation study, the drug substance cangrelor was found to be sensitive towards acidic, basic and oxidative conditions. Besides, it was stable under thermal and photolytic stress conditions. The degradation products were characterized by using advanced LC/QTOF and MS/MS analysis. Further, the structures were characterized by NMR studies. The identified degradation products of cangrelor are valuable for cangrelor manufacturing process and quality control., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Forced degradation study of argatroban under conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH Q1A (R2), was accomplished. The drug showed significant degradation under hydrolysis (acidic, alkaline) and oxidation (peroxide stress) conditions. The drug remained stable under thermal and photolytic stress conditions. In total, seven novel degradation products (DP - 1 to DP - 7) were found under diverse conditions, which were not reported earlier. The chemical structures of these degradation products were characterized by 1 H NMR, 13 C NMR, 2D NMR, Q-TOF-MS n and IR spectral analysis and the proposed degradation products structures were further confirmed by the individual synthesis.