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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Published inOrganic process research & development Vol. 25; no. 8; pp. 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 Journal Article
LanguageEnglish
Published American Chemical Society 20.08.2021
Subjects
electrochemical detection
cyanide
control strategy
safety
chloroacetonitrile
ion chromatography
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Abstract 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.
AbstractList 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.
Author Song, Siqing
Di Maso, Michael J
Ren, Hong
Arvary, Rebecca
Zompa, Michael A
Jellett, Lisa
Guzman, Francisco
Zhao, Ralph
Lohani, Sachin
Chang, Darryl
AuthorAffiliation Department of Process Research and Development, MRL
Analytical Research and Development, MRL
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CitedBy_id crossref_primary_10_1021_acs_oprd_1c00360
crossref_primary_10_1016_j_dyepig_2022_110941
crossref_primary_10_1021_acs_orglett_3c03052
crossref_primary_10_1021_acs_analchem_1c04224
crossref_primary_10_1002_ejoc_202200249
crossref_primary_10_1021_acs_joc_2c02395
Cites_doi 10.1021/i360049a014
10.1016/j.aca.2010.05.042
10.1021/jo962185r
10.1021/acs.oprd.0c00248
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Keywords electrochemical detection
cyanide
control strategy
safety
chloroacetonitrile
ion chromatography
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Snippet The manufacturing route toward gefapixant citrate generates a trace amount of cyanide as a byproduct of a reaction employing the reagent chloroacetonitrile. In...
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Title A Holistic Strategy for Cyanide Control and Safety for Pharmaceutical Manufacturing
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