Three-Pronged Approach (Active Pharmaceutical Ingredients, Excipients, and NOx-Free Air) Successfully Suppressed the Formation of Nitroso-atomoxetine to 0.097 ppm

IF 3.5 3区化学 Q2 CHEMISTRY, APPLIED

Organic Process Research & Development Pub Date : 2025-08-22 DOI:10.1021/acs.oprd.5c00182

Ryota Nomura*, Takahiko Taniguchi, Koji Kitada, Mamoru Otsuki, Takuma Tamai, Kazuya Suzuoki, Rintaro Yokoi, Kanako Kondo and Osamu Uchikawa,

引用次数: 0

Abstract

News of “carcinogenic nitrosamines in pharmaceutical products” circulates around the world, and regulatory agencies and pharmaceutical companies are facing challenges in reducing the presence of nitrosamines. A variety of causes affect the presence of nitrosamine and complicate the mitigation process. However, our three-pronged approach combining empirical knowledge has successfully reduced the level of nitroso-atomoxetine to 0.097 ppm.

查看原文本刊更多论文

三管齐下（有效药物成分，赋形剂和无nox空气）成功地将亚硝基托莫西汀的形成抑制到0.097 ppm

“药品中含有致癌性亚硝胺”的消息在世界各地流传，监管机构和制药公司在减少亚硝胺的存在方面面临挑战。多种原因影响亚硝胺的存在，使减缓过程复杂化。然而，我们的三管齐下的方法结合经验知识已经成功地将亚硝基托莫西汀的水平降低到0.097 ppm。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Organic Process Research & Development 化学-应用化学

CiteScore

6.90

自引率

14.70%

发文量

251

审稿时长

2 months

期刊介绍： The journal Organic Process Research & Development serves as a communication tool between industrial chemists and chemists working in universities and research institutes. As such, it reports original work from the broad field of industrial process chemistry but also presents academic results that are relevant, or potentially relevant, to industrial applications. Process chemistry is the science that enables the safe, environmentally benign and ultimately economical manufacturing of organic compounds that are required in larger amounts to help address the needs of society. Consequently, the Journal encompasses every aspect of organic chemistry, including all aspects of catalysis, synthetic methodology development and synthetic strategy exploration, but also includes aspects from analytical and solid-state chemistry and chemical engineering, such as work-up tools，process safety, or flow-chemistry. The goal of development and optimization of chemical reactions and processes is their transfer to a larger scale; original work describing such studies and the actual implementation on scale is highly relevant to the journal. However, studies on new developments from either industry, research institutes or academia that have not yet been demonstrated on scale, but where an industrial utility can be expected and where the study has addressed important prerequisites for a scale-up and has given confidence into the reliability and practicality of the chemistry, also serve the mission of OPR&D as a communication tool between the different contributors to the field.