A study on structural characterization of potential impurities of Sugammadex sodium using LC/ESI/QTOF/MS/MS and NMR.

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 study on structural characterization of degradation products of cangrelor using LC/QTOF/MS/MS and NMR.

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.

Novel degradation products of argatroban: Isolation, synthesis and extensive characterization using NMR and LC-PDA-MS/Q-TOF.

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.