一般財団法人 医薬品医療機器
レギュラトリーサイエンス財団 医薬標準品センター

Absolute purity determination of an organic fluorine pharmaceutical voriconazole via quantitative ¹⁹F-NMR and method validation: Nahoko Uchiyama, Junko Hosoe, Kohei Kiyota, Takanori Komatsu, Naoki Sugimoto, Kyoko Ishizuki, Tatsuo Koide, Mika Murabayashi, Taeko Shinozaki, Yoshinori Fujimine, Katsuya Ofuji, Hitoshi Shimizu, Kazuhiro Fujita, Takashi Hasebe, Yumi Asai, Eri Ena, Yoshinobu Makino, Toru Miura, Yasuhiro Muto, Katsuo Asakura, Takako Suematsu, Hitomi Abe, Ai Kohama, Takashi Goto, Masu Yasuda, Tomohiko Ueda, Yukihiro Goda. Journal of Pharmaceutical and Biomedical Analysis Open Volume 4, December 2024, 100039

Quantitative ³¹P-NMR for the Purity Determination of the Organophosphorus Compound Brigatinib and Its Method Validation: Uchiyama N, Hosoe J, Komatsu T, Sugimoto N, Ishizuki K, Koide T, Murabayashi M, Shinozaki T, Kobayashi K, Fujimine Y, Ofuji K, Shimizu H, Hasebe T, Asai Y, Ena E, Kiyota K, Fujita K, Makino Y, Miura T, Muto Y, Asakura K, Suematsu T, Muto H, Kohama A, Goto T, Yasuda M, Ueda T, Goda Y. Chem Pharm Bull, 72, 36-40 (2024)

Quality Evaluation of Gentamicin Sulfate Reference Standards in Japanese Pharmacopoeia Using Hydrophilic Interaction Chromatography Combined With Tandem Mass Spectrometry: Maekawa K, Sawa R, Matsui M, Konda T, Kubota Y, Matsuo A, Maeda A, Takahashi C, Tanimoto T, Nakagawa Y, Yoneda S, Mori Y, Susuki S. Journal of AOAC INTERNATIONAL, 107, 234-241 (2024)

日局医薬品各条合成グルカゴンの定量法等に関する研究：橋井則貴，蛭田葉子，林 真由美，海老澤亜樹子，中川ゆかり，石井明子．医薬品医療機器レギュラトリーサイエンス，54(5) 428-438 (2023)

Collaborative Study of Bacterial Endotoxins Test Using Recombinant Factor C-Based Procedure for Detection of Lipopolysaccharides (Part 3): Kikuchi Y, Muroi M, Nakagawa Y, Ebisawa A, Hayashi M, Takeuchi H, Kiwamoto Y, Matsumura K, Yoshimoto R, Tsuzuki N, Oikawa N, Hashimoto M, Hiramatsu Y, Fukami M, Kobayashi K, Sanda N, Eto S, Mori M, Martinez O, Suzuki M, Sekiguchi S, Ouchi K, Fukuchi H, Kitagawa T, Kizawa M, Masuda T, Oda T, Mizumura H, Ogura N, Iida D, Sueoka K, Tanno Y, Tsuchiya M．医薬品医療機器レギュラトリーサイエンス，54(4) 341-351 (2023)

取扱い環境により容易に転移するチアミン塩化物塩酸塩の擬似結晶多形の識別手法：山田彩乃，村尾 渚，佐藤明啓，藤本雄三，中川ゆかり，谷本 剛．YAKUGAKU ZASSHI，142 295-302 （2022）

Quantitative ³¹P-NMR for Purity Determination of Sofosbuvir and Method Validation: Uchiyama N, Kiyota K, Hosoe J, Komatsu T, Sugimoto N, Ishizuki K, Koide T, Murabayashi M, Kobayashi K, Fujimine Y, Yokose T, Ofuji K, Shimizu H, Hasebe T, Asai Y, Ena E, Kikuchi J, Fujita K, Makino Y, Iwamoto Y, Miura T, Muto Y, Asakura K, Suematsu T, Muto H, Kohama A, Goto T, Yasuda M, Ueda T, Goda Y. Chem Pharm Bull, 70, 892-900 (2022)

Purity Determination of Cyclophosphamide Hydrate by Quantitative ³¹P-NMR and Method Validation: Uchiyama N, Hosoe J, Sugimoto N, Ishizuki K, Koide T, Murabayashi M, Miyashita N, Kobayashi K, Fujimine Y, Yokose T, Ofuji K, Shimizu H, Hasebe T, Asai Y, Ena E, Kikuchi J, Kiyota K, Fujita K, Makino Y, Yasobu N, Iwamoto Y, Miura T, Mizui K, Asakura K, Suematsu T, Muto H, Kohama A, Goto T, Yasuda M, Ueda T, Goda Y. Chem Pharm Bull, 69, 630-638 (2021)

Absolute purity determination of a hygroscopic substance, indocyanine green, using quantitative NMR (qNMR): Uchiyama N, Hosoe J, Sugimoto N, Ishizuki K, Koide T, Murabayashi M, Miyashita N, Kobayashi K, Fujimine Y, Yokose T, Ofuji K, Shimizu H, Hasebe T, Asai Y, Ena E, Kikuchi J, Kiyota K, Fujita K, Makino Y, Yasobu N, Yamada Y, Iwamoto Y, Miura T, Mizui K, Asakura K, Suematsu T, Kohama A, Goda Y. Chem Pharm Bull, 69, 118-123 (2021)

Substandard and Falsified Medicines in Myanmar: Sakuda M, Yoshida N, Takaoka T, Sanada T, Rahman MS, Tanimoto T, Zin T, Kimura K, Tsuboi H. Pharmacy, 8, 45-55 (2020); DOI:10.3390/pharmacy8010045

A Cross-Sectional Investigation for Verification of Globalization of Falsified Medicines in Cambodia, Indicated by Tablets of Sildenafil Citrate: Yoshida N, Yuasa M, Sovannarith T, Dararth E, Keila T, Kiet HB, Tsuboi H, Tanimoto T, Kimura K. Pharmacy, 7,111-121 (2019); DOI:10.3390/pharmacy7030111

日局新規収載候補日局グルカゴン各条試験法に関する研究 液体クロマトグラフィーを用いた合成グルカゴン定量法の検討：鈴木琢雄，森岡知子，林 真由美，東阪嘉子，蛭田葉子，橋井則貴，中川ゆかり，石井明子．医薬品医療機器レギュラトリーサイエンス，49(7) 488-497 (2018)

Quality of omeprazole purchased via the internet and personally imported into Japan: Comparison with products sampled in other Asian countries: Rahman MS, Yoshida N, Sugiura S, Tsuboi H, Keila T, Kiet HB, Zin T, Tanimoto T, Kimura K. Trop Med Int Health, 23(3), 263-269 (2018)

An Investigation into the Quality of Medicines in Yangon, Myanmar: Islam MR, Yoshida N, Kimura K, Uwatoko C, Rahman MS, Kumada S, Endo J, Ito K, Tanimoto T, Zin T, Tsuboi H. Pharmacy, 6, 96-106 (2018); DOI:10.3390/pharmacy6030096

Four-year survey of the quality of antimicrobial medicines in Cambodia: Islam MR, Yoshida N, Tsuboi H, Sovannarith T, Dararath E, Kiet HB, Sokchamroeum U, Keila T, Tanimoto T, Kimura K. J Int Health, 32(4), 233-242 (2017)

Erroneous formulation of delayed-release omeprazole capsules: alert for importing countries：Rahman MS, Yoshida N, Tsuboi H, Keila T, Sovannarith T, Kiet HB, Dararth E, Zin T, Tanimoto T, Kimura K，BMC Pharmaco Toxico ，18(1), 31-41 (2017); DOI:10.1186/s40360-017-0138-5

Survey of peptide quantification methods and comparison of their reproducibility: A case study using oxytocin: Li CS, Bhavaraju S, Thibeault M-P, Melanson J, Blomgren A, Rundlöf T, Kilpatrick E, Swann CJ, Rudd T, Aubin Y, Grant K, Butt M, Shum Y, Kerim T, Sherwin W, Nakagawa Y, Pavón S, Arrastia S, Weel T, Pola A, Chalasani D, Walfish S, Atouf F. J Pharma Biomed Anal, 166, 105-112 (2016)

日本薬局方各条ヘパリン定量法の改良に関わる研究：鈴木琢雄，石井明子，西村和子，日向昌司，橋井則貴，中川ゆかり，森岡知子，田邉利史，藤田奈穂，余田 光，嶋村英雄，倉田康憲，福田純也，小山定利，川崎ナナ．医薬品医療機器レギュラトリーサイエンス，46(11) 797-806 (2015）

Study on health hazards through medicines purchased on the Internet: a cross-sectional investigation of the quality of anti-obesity medicines containing crude drugs as active ingredients：Yoshida N, Numano M, Nagasaka Y, Ueda K, Tsuboi H, Tanimoto T, Kimura K. BMC Complemen Alterna Med, 15(1) 430-439 (2015); DOI:10.1186/s12906-015-0955-2