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Development and Validation of an ICP MS Method - Almac

Journal of Pharmaceutical and Biomedical Analysis 145 (2017) 84 90 Contents lists available atScienceDirectJournal of Pharmaceutical and Biomedical Analysisjournal and Validation of an ICP-MS Method for thedetermination of elemental impurities in TP-6076 activepharmaceutical ingredient (API) according to USP 232 / 233 Osama Chahroura, , John Malonea, Mark Collinsa, Vrushali Salmona, Catherine Greenana,Amy Bombardierb, Zhongze Mab, Nick DunwoodybaAlmac House, 20 Seagoe Industrial Estate, Craigavon, BT63 5QD, UKbTetraphase, 480 Arsenal Way, Ste #110, Watertown, MA 02472, United States of Americaa r t i c l e i n f oArticle history:Received 4 April 2017 Received in revised form 13 June 2017 Accepted 17 June 2017 Available online 20 June 2017a b s t r a c tThe new guidelines of the United States pharmacopeia (USP), European pharmacopeia (EP) and inter-national conference on harmonization (ICH) regulating elemental impurities limits in pharmaceuticalssignify the end of unspecific analysis of metals as outlined in USP 231.

and validation of an ICP-MS method for the determination of elemental impurities in TP-6076 active pharmaceutical ingredient (API) according to USP 232 / 233 ... effective removal of most common polyatomic interfer-ences were (He gas flow is approximately 5mL/min). He mode provides ... interferences. An Agilent ASX-520 auto-sampler was used to ...

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  Interference, Ence, Polyatomic, Polyatomic interfer ences, Interfer

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