A Holistic Strategy for Cyanide Control and Safety for Pharmaceutical Manufacturing

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 incompati...

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Bibliographic Details
Published in:Organic process research & development 2021-08, Vol.25 (8), p.1937-1942
Main Authors: Zompa, Michael A, Di Maso, Michael J, Guzman, Francisco, Zhao, Ralph, Jellett, Lisa, Arvary, Rebecca, Song, Siqing, Chang, Darryl, Ren, Hong, Lohani, Sachin
Format: Article
Language:English
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Summary: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.
ISSN:1083-6160
1520-586X
DOI:10.1021/acs.oprd.1c00185