Collaborative Study to Validate Purity Determination by <sup>1</sup>H Quantitative NMR Spectroscopy by Using Internal Calibration Methodology.

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作者： Toru,Miura ^[1] ; Naoki,Sugimoto ^[2] ; Sitaram,Bhavaraju ^[3] ; Taichi,Yamazaki ^[4] ; Yuzo,Nishizaki ^[2] ; Yang,Liu ^[3] ; Anton,Bzhelyansky ^[3] ; Carlos,Amezcua ^[5] ; Joseph,Ray ^[6] ; Elina,Zailer ^[5] ; Bernd,Diehl ^[7] ; Vito,Gallo ^[8] ; Stefano,Todisco ^[8] ; Katsuya,Ofuji ^[9] ; Kazuhiro,Fujita ^[9] ; Taro,Higano ^[10] ; Christian,Geletneky ^[11] ; Thomas,Hausler ^[12] ; Neeraj,Singh ^[13] ; Kana,Yamamoto ^[13] ; Tsuyoshi,Kato ^[13] ; Ryuichi,Sawa ^[14] ; Ryuichi,Watanabe ^[14] ; Yoshiaki,Iwamoto ^[15] ; Yukihiro,Goda ^[16]

作者单位： FUJIFILM Wako Pure Chemical Corporation. ^[1] National Institute of Health Sciences. ^[2] United States Pharmacopeial Convention. ^[3] National Metrology Institute of Japan/National Institute of Advanced Industrial Science and Technology. ^[4] Baxter Healthcare. ^[5] FMC Corporation. ^[6] University of Illinois at Chicago. ^[7] Spectral Service AG. ^[8] Polytechnic University of Bari. ^[9] Chugai Pharma Manufacturing Co., Ltd. ^[10] SHIONOGI & Co., Ltd. ^[11] Taisho Pharmaceutical Co., Ltd. ^[12] Roche Diagnostics GmbH. ^[13] Japan Food Research Laboratories. ^[14] Microbial Chemistry Research Foundation. ^[15] National Research Institute of Fisheries Science. ^[16]

关键词 collaborative study measurement uncertainty method validation metrological traceability quantitative (q)NMR