Transcription of Journal of Pharmaceutical and Biomedical Analysis
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Journal of Pharmaceutical and Biomedical Analysis
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.
double-blind, single-ascending dose phase 1 study is evaluating the safety and pharmacokinetics of TP-6076. The study being conducted under aclinical trial authorisation in single centre in up to 32 healthy volunteers. Experimental 2.1. Chemical and laboratory reagents Trace metal grade concentrated acetic acid (Fisher Chemical), trace
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