{"id":12849,"date":"2025-12-26T16:09:41","date_gmt":"2025-12-26T07:09:41","guid":{"rendered":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/?p=12849"},"modified":"2026-02-26T18:28:59","modified_gmt":"2026-02-26T09:28:59","slug":"%e3%80%90%e7%a0%94%e7%a9%b6%e5%ae%9f%e7%b8%be%e3%80%91-%e3%83%8b%e3%83%88%e3%83%ad%e3%82%bd%e3%82%a2%e3%83%9f%e3%83%b3%e9%a1%9e%e3%83%aa%e3%82%b9%e3%82%af%e4%bd%8e%e6%b8%9b%e3%81%ab%e5%90%91%e3%81%91","status":"publish","type":"post","link":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/pick-up\/p12849\/","title":{"rendered":"[Research Achievement] Revolutionizing Nitrosamine Risk Mitigation: Direct Structure Determination with 3D ED \/ MicroED (Joint Research with Rigaku Corporation)"},"content":{"rendered":"

A new research paper authored by Keiyo Nakai, Kuniyoshi Miki, Natsuki Hashimoto, Mitsuhisa Yamano, et al.<\/em>, has been published in Org. Process Res. Dev. 2025 (ASAP).<\/em><\/p>\n

 <\/p>\n

Journal: \u3000\u3000Org. Process Res. Dev. 2025 (ASAP)<\/em><\/strong><\/span><\/p>\n

Title: \u3000\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Structure Determination of Synthesized Nitrosamine <\/strong><\/span>
\n \u3000\u3000\u3000\u3000\u00a0 \u00a0 \u00a0 \u00a0 \u00a0Drug Substance-Related Impurities (NDSRIs) Using 3D ED\/MicroED<\/strong><\/span><\/p>\n

URL:<\/strong> \u3000\u00a0 \u3000\u00a0 \u00a0 https:\/\/doi.org\/10.1021\/acs.oprd.5c00236<\/a><\/span><\/p>\n

Authors: \u3000\u00a0 1<\/sup>Keiyo Nakai*, 1<\/sup>Yuki Ejima, 2<\/sup>Takashi Kikuchi, 1<\/sup>Kuniyoshi Miki,<\/strong><\/span><\/p>\n

\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a01<\/sup>Natsuki Hashimoto, <\/strong><\/span>\u00a01<\/sup>Mitsuhisa Yamano<\/strong><\/span><\/p>\n

Affiliations:\u00a0 \u00a01<\/sup>SPERA PHARMA, Inc.\u30002<\/sup>Rigaku Corporation\u3000<\/strong><\/span><\/p>\n

 <\/p>\n

Summary<\/strong>:<\/strong><\/p>\n

3D Electron Diffraction (3D ED) \/ MicroED is changing the game in nitrosamine risk mitigation.<\/strong><\/p>\n

Our latest study demonstrates how this cutting-edge technology enables rapid and precise structure determination of NDSRIs (Nitrosamine Drug Substance-Related Impurities).<\/p>\n

n recent years, nitrosamine contamination risk has become a critical global issue for the pharmaceutical industry. When a potential risk is identified, rapid implementation of mitigation measures is required, with the core steps being reference standard synthesis and structural confirmation.
\nHowever, current practice often relies on indirect evidence from MS (mass spectrometry), \u00b9H-NMR(nuclear magnetic resonance), and \u00b9\u00b3C-NMR, leading to conclusions that are merely \u201clikely correct.\u201d In fact, even commercially available nitrosamines have been found to contain structural errors upon precise analysis.<\/p>\n

By applying 3D ED \/ MicroED to the structural determination of various NDSRIs, we achieved the following groundbreaking results:<\/p>\n

\u3000\u3000\u25a0 Analysis of microcrystalline nitrosamines without electron-beam damage<\/strong><\/p>\n

\u3000\u3000\u25a0 Exceptional utility in identifying rotational and positional isomers<\/strong><\/p>\n

\n

 <\/p>\n

This technology dramatically improves the accuracy of structural determination in nitrosamine risk mitigation, accelerating risk assessment and regulatory compliance.<\/p>\n<\/div>\n

 <\/p>\n

SPERA PHARMA\u2019s Comprehensive Solutions<\/strong><\/p>\n

\n

We provide end-to-end support\u2014from nitrosamine risk assessment<\/strong> to quantitative supply of reference standard<\/strong>s and development of analytical methods<\/strong> using those standards.
\nFurthermore, for crystalline powders and mixtures where conventional X-ray analysis struggles, we leverage 3D ED \/ MicroED technology to deliver solutions that overcome these challenges.<\/p>\n

 <\/p>\n

Ready to accelerate your research?\u00a0Contact us today to explore 3D ED \/ MicroED solutions for your structural challenges.<\/p>\n

 <\/p>\n<\/div>\n

Inquiry<\/span><\/a>\n","protected":false},"excerpt":{"rendered":"

A new research paper authored by Keiyo Nakai, Kuniyoshi Miki, Natsuki Hashimoto, Mitsuhisa Yamano, et al., has […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_locale":"en_US","_original_post":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/?p=12795","footnotes":""},"categories":[4,6],"tags":[84,74,98,85],"class_list":["post-12849","post","type-post","status-publish","format-standard","hentry","category-pick-up","category-news","tag-3d-ed","tag-microed","tag-nitrosamine","tag-spera-pharma","en-US"],"acf":[],"_links":{"self":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/posts\/12849","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/comments?post=12849"}],"version-history":[{"count":9,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/posts\/12849\/revisions"}],"predecessor-version":[{"id":13002,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/posts\/12849\/revisions\/13002"}],"wp:attachment":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/media?parent=12849"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/categories?post=12849"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/tags?post=12849"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}