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AN72502: Assay of Sodium Thiosulfate and Ionic Impurities in Sodium Thiosulfate Using Ion Chromatography- (Part 2-Impurities)
Description
Sodium thiosulfate is approved for the treatment of acute cyanide poisoning. An ion chromatography (IC) method has been proposed to replace existing titration-based assays in the Sodium Thiosulfate and its Injection monographs. Another IC method has also been proposed for determining impurities. This application note evaluates both methods following the USP guidelines (<1225>, Validation of Compendial Methods). A Dionex ICS-5000+ IC system with a Dionex IonPac AS12A column and suppressed conductivity detection were used for both method evaluations. An ICS-6000 can be used for this application.Market: | Pharma |
Keywords: | Drug Substance, ICS-5000+, Pharmaceutical, USP monograph, Sulfite, Impurity, Chloride, Sulfate, suppressed conductivity detection, Drug Product, Dionex IonPac AS12A Column, Sodium thiosulfate, <1225>, United States Pharmacopeia, ICS-6000 |
Matrix: | Drug product, Drug substance, Sodium Thiosulfate |
Author: | Hua Yang and Jeffrey Rohrer |
Affiliation: | Thermo Fisher Scientific, Sunnyvale, CA USA |
For Research Use Only. Not for use in diagnostic procedures.