A Holistic Strategy for Cyanide Control and Safety for Pharmaceutical Manufacturing,Organic Process Research & Development

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A Holistic Strategy for Cyanide Control and Safety for Pharmaceutical Manufacturing
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2021-08-09 , DOI: 10.1021/acs.oprd.1c00185
Michael A. Zompa ₁ , Michael J. Di Maso ₂ , Francisco Guzman ₂ , Ralph Zhao ₂ , Lisa Jellett ₂ , Rebecca Arvary ₁ , Siqing Song ₁ , Darryl Chang ₂ , Hong Ren ₂ , Sachin Lohani ₁

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The manufacturing route toward gefapixant citrate generates a trace amount of cyanide as a byproduct of a reaction employing the reagent chloroacetonitrile. In the development of a cyanide control strategy, conventional process and analytical approaches fell short because of challenges and incompatibilities with the matrices of the process and waste streams. To overcome these, we identified and adapted specific procedures for cyanide control. Our strategy ensured safety for patients, operators, and waste management.

中文翻译：

用于药物制造的氰化物控制和安全的整体策略

生产柠檬酸吉法吡酯的路线会产生痕量氰化物，作为使用氯乙腈试剂的反应副产物。在开发氰化物控制策略时，由于工艺和废物流的基质存在挑战和不兼容性，传统工艺和分析方法无法实现。为了克服这些问题，我们确定并调整了氰化物控制的具体程序。我们的策略确保了患者、操作者和废物管理的安全。

更新日期：2021-08-20

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