{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T17:39:29Z","timestamp":1787161169141,"version":"build-2736575974"},"reference-count":22,"publisher":"Pharmaceutical Society of Japan","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Chem. Pharm. Bull.","CHEMICAL &amp; PHARMACEUTICAL BULLETIN"],"published-print":{"date-parts":[[2021,7,1]]},"DOI":"10.1248\/cpb.c21-00109","type":"journal-article","created":{"date-parts":[[2021,4,14]],"date-time":"2021-04-14T18:06:45Z","timestamp":1618423605000},"page":"630-638","source":"Crossref","is-referenced-by-count":10,"title":["Purity Determination of Cyclophosphamide Hydrate by Quantitative &lt;sup&gt;31&lt;\/sup&gt;P-NMR and Method Validation"],"prefix":"10.1248","volume":"69","author":[{"given":"Nahoko","family":"Uchiyama","sequence":"first","affiliation":[{"name":"National Institute of Health Sciences (NIHS)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junko","family":"Hosoe","sequence":"additional","affiliation":[{"name":"National Institute of Health Sciences (NIHS)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Sugimoto","sequence":"additional","affiliation":[{"name":"National Institute of Health Sciences (NIHS)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyoko","family":"Ishizuki","sequence":"additional","affiliation":[{"name":"National Institute of Health Sciences (NIHS)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuo","family":"Koide","sequence":"additional","affiliation":[{"name":"National Institute of Health Sciences (NIHS)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mika","family":"Murabayashi","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceutical Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoto","family":"Miyashita","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kengo","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinori","family":"Fujimine","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiyuki","family":"Yokose","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuya","family":"Ofuji","sequence":"additional","affiliation":[{"name":"Chugai Pharma Manufacturing Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hitoshi","family":"Shimizu","sequence":"additional","affiliation":[{"name":"Chugai Pharma Manufacturing Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Hasebe","sequence":"additional","affiliation":[{"name":"Eisai Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumi","family":"Asai","sequence":"additional","affiliation":[{"name":"Eisai Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eri","family":"Ena","sequence":"additional","affiliation":[{"name":"Eisai Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junko","family":"Kikuchi","sequence":"additional","affiliation":[{"name":"SHIONOGI & Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kohei","family":"Kiyota","sequence":"additional","affiliation":[{"name":"SHIONOGI & Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiro","family":"Fujita","sequence":"additional","affiliation":[{"name":"SHIONOGI & Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinobu","family":"Makino","sequence":"additional","affiliation":[{"name":"Juzen Chemical Corp."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoko","family":"Yasobu","sequence":"additional","affiliation":[{"name":"FUJIFILM Corporation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiaki","family":"Iwamoto","sequence":"additional","affiliation":[{"name":"FUJIFILM Wako Pure Chemical Corporation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Miura","sequence":"additional","affiliation":[{"name":"FUJIFILM Wako Pure Chemical Corporation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Mizui","sequence":"additional","affiliation":[{"name":"FUJIFILM Wako Pure Chemical Corporation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuo","family":"Asakura","sequence":"additional","affiliation":[{"name":"JEOL Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takako","family":"Suematsu","sequence":"additional","affiliation":[{"name":"JEOL RESONANCE Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hitomi","family":"Muto","sequence":"additional","affiliation":[{"name":"JEOL RESONANCE Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ai","family":"Kohama","sequence":"additional","affiliation":[{"name":"Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Goto","sequence":"additional","affiliation":[{"name":"Nippon Shinyaku Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masu","family":"Yasuda","sequence":"additional","affiliation":[{"name":"Nippon Shinyaku Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiko","family":"Ueda","sequence":"additional","affiliation":[{"name":"Sumitomo Dainippon Pharma Co., Ltd."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukihiro","family":"Goda","sequence":"additional","affiliation":[{"name":"National Institute of Health Sciences (NIHS)"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"163","reference":[{"key":"1","unstructured":"1) The Ministry of Health, Labour and Welfare, Japan, \u201cThe Japanese Pharmacopoeia Seventeenth Edition (2016).\u201d: \u2039https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/JP17_REV_1.pdf\u203a, cited 10 March, 2020."},{"key":"2","unstructured":"2) The Ministry of Health, Labour and Welfare, Japan, \u201cSupplement I to The Japanese Pharmacopoeia Seventeenth Edition (2017).\u201d: \u2039https:\/\/www.mhlw.go.jp\/content\/11120000\/000352508.pdf\u203a, cited 10 March, 2020."},{"key":"3","unstructured":"3) The Ministry of Health, Labour and Welfare, Japan, \u201cSupplement II to The Japanese Pharmacopoeia Seventeenth Edition (2019).\u201d: \u2039https:\/\/www.mhlw.go.jp\/content\/11120000\/000597173.pdf\u203a, cited 10 March, 2020."},{"key":"4","unstructured":"4) The Ministry of Health, Labour and Welfare, Japan, \u201cThe Japanese Pharmacopoeia Seventeenth Edition (2016), General Information, Quantitative Analytical Technique Utilizing Nuclear Magnetic Resonance (NMR) Spectroscopy and its Application to Reagents in the Japanese Pharmacopoeia.\u201d: \u2039https:\/\/www.pmda.go.jp\/files\/000217666.pdf\u203a, cited 10 March, 2020."},{"key":"5","unstructured":"5) Pharmaceuticals and Medical Devices Agency (PMDA), \u201cJP drafts for public comments. (3 June, 2019),\u201d cited 10 March, 2020."},{"key":"6","unstructured":"6) Pharmaceuticals and Medical Devices Agency (PMDA), \u201cByakkokaninjinto Extract (3 June, 2019),\u201d cited 10 March, 2020."},{"key":"7","unstructured":"7) Pharmaceuticals and Medical Devices Agency (PMDA), \u201cJP drafts for public comments (3 June, 2019.)\u201d: \u2039https:\/\/www.pmda.go.jp\/files\/000229718.pdf\u203a, cited 16 January, 2021."},{"key":"8","unstructured":"8) Pharmaceuticals and Medical Devices Agency (PMDA), \u201cJP drafts for public comments (2 September, 2019).\u201d: \u2039https:\/\/www.pmda.go.jp\/files\/000231158.pdf\u203a, cited 16 January, 2021."},{"key":"9","unstructured":"9) Hosoe J., Sugimoto N., Goda Y., <i>Pharmaceutical and Medical Device Regulatory Science<\/i>, <b>41<\/b>, 960\u2013970 (2010)."},{"key":"10","unstructured":"10) Hosoe J., Sugimoto N., Suematsu T., Yamada Y., Hayakawa M., Katsuhara T., Nishimura H., Goda Y., <i>Pharmaceutical and Medical Device Regulatory Science<\/i>, <b>43<\/b>, 182\u2013193 (2012)."},{"key":"11","unstructured":"11) Hosoe J., Sugimoto N., Suematsu T., Yamada Y., Miura T., Hayakawa M., Suzuki H., Katsuhara T., Nishimura H., Kikuchi Y., Yamashita T., Goda Y., <i>Pharmaceutical and Medical Device Regulatory Science<\/i>, <b>45<\/b>, 243\u2013250 (2014)."},{"key":"12","unstructured":"12) Goda Y., <i>Pharmaceutical and Medical Device Regulatory Science<\/i>, <b>48<\/b>, 615\u2013619 (2017)."},{"key":"13","doi-asserted-by":"crossref","unstructured":"13) Uchiyama N., Hosoe J., Miura T., Sugimoto N., Ishizuki K., Yamada Y., Iwamoto Y., Suematsu T., Komatsu T., Maruyama T., Igarashi Y., Higano T., Shimada N., Goda Y., <i>Yakugaku Zasshi<\/i>, <b>140<\/b>, 1063\u20131069 (2020).","DOI":"10.1248\/yakushi.20-00066"},{"key":"14","doi-asserted-by":"crossref","unstructured":"14) Uchiyama N., Hosoe J., Miura T., Sugimoto N., Ishizuki K., Yamada Y., Iwamoto Y., Suematsu T., Komatsu T., Maruyama T., Igarashi Y., Higano T., Shimada N., Goda Y., <i>Chem. Pharm. Bull.<\/i>, <b>69<\/b>, 26\u201331 (2021).","DOI":"10.1248\/cpb.c20-00296"},{"key":"15","doi-asserted-by":"crossref","unstructured":"15) Uchiyama N., Hosoe J., Sugimoto N., <i>et al.<\/i>, <i>Chem. Pharm. Bull.<\/i>, <b>69<\/b>, 118\u2013123 (2021).","DOI":"10.1248\/cpb.c20-00728"},{"key":"16","doi-asserted-by":"crossref","unstructured":"16) Kato T., Nishimiya M., Kawata A., Kishida K., Suzuri K., Saito M., Fujita K., Igarashi T., Inagaki M., <i>J. Oleo Sci.<\/i>, <b>67<\/b>, 1279\u20131289 (2018).","DOI":"10.5650\/jos.ess18062"},{"key":"17","doi-asserted-by":"publisher","unstructured":"17) Weber M., Hellriegel C., Rueck A., Wuethrich J., Jenks P., Obkircher M., <i>Anal. Bioanal. Chem.<\/i>, <b>407<\/b>, 3115\u20133123 (2015). doi: 10.1007\/s00216-014-8306-6.","DOI":"10.1007\/s00216-014-8306-6"},{"key":"18","doi-asserted-by":"publisher","unstructured":"18) Rigger R., R\u00fcck A., Hellriegel C., Sauermoser R., Morf F., Breitruck K. B., Obkircher M., <i>J. AOAC Int.<\/i>, <b>100<\/b>, 1365\u20131375 (2017). doi: 10.5740\/jaoacint.17-0093.","DOI":"10.5740\/jaoacint.17-0093"},{"key":"19","unstructured":"19) qNMR primary guide working group, \u201cqNMR primary guide. A guide to quantitative analysis for beginners\u2014from basics to practice,\u201d Kyoritsu publication, Tokyo, 2015, pp. 96\u201397."},{"key":"20","unstructured":"20) \u201cEuropean Directorate for the Quality of Medicines. European Pharmacopoeia 10.0,\u201d Council of Europe, Strasbourg, France, 2019, p. 2326."},{"key":"21","doi-asserted-by":"crossref","unstructured":"21) Sugimoto N., Tada A., Suematsu T., Arifuku K., Saito T., Ihara T., Yoshida Y., Kubota R., Tahara M., Shimizu K., Ito S., Yamazaki T., Kawamura Y., Nishimura T., <i>Shokuhin Eiseigaku Zasshi (Food Hygiene and Safety Science)<\/i>, <b>51<\/b>, 19\u201327 (2010).","DOI":"10.3358\/shokueishi.51.19"},{"key":"22","unstructured":"22) Sato-Masumoto N., Nishizaki Y., Saito N., Yamazaki T., Numata M., Ihara T., Sugimoto N., Sato K., <i>Nippon Shokuhin Kagaku Gakkaishi (Jpn. J. Food Chem. Safety)<\/i>, <b>24<\/b>, 75\u201381 (2017)."}],"container-title":["Chemical and Pharmaceutical Bulletin"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/cpb\/69\/7\/69_c21-00109\/_pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,12,24]],"date-time":"2022-12-24T03:56:03Z","timestamp":1671854163000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/cpb\/69\/7\/69_c21-00109\/_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,1]]},"references-count":22,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2021]]}},"URL":"https:\/\/doi.org\/10.1248\/cpb.c21-00109","relation":{},"ISSN":["0009-2363","1347-5223"],"issn-type":[{"value":"0009-2363","type":"print"},{"value":"1347-5223","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,1]]},"article-number":"c21-00109"}}