Prediction of N-Nitrosamine Partition Coefficients for Derisking Drug Substance Manufacturing Processes-Reference-Cited by-同舟云学术

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Prediction of N-Nitrosamine Partition Coefficients for Derisking Drug Substance Manufacturing Processes

Published:2021-03-25 Issue:4 Volume:25 Page:871-883
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Ashworth Ian W.¹^ORCID,Curran Timothy T.²^ORCID,Ford J. Gair³,Tomasi Simone¹^ORCID

Affiliation:

1. Chemical Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, U.K.

2. Process Chemistry, Vertex Pharmaceuticals, Boston, Massachusetts, United States

3. Regulatory CMC, Global Regulatory Excellence, AstraZeneca, Macclesfield, U.K.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.0c00535

Reference62 articles.

1. Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products

2. The contamination of valsartan and other sartans, part 1: New findings

3. The contamination of valsartan and other sartans, Part 2: Untargeted screening reveals contamination with amides additionally to known nitrosamine impurities

4. Regulatory Highlights

5. The Production of Malignant Primary Hepatic Tumours in the Rat by Feeding Dimethylnitrosamine

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1. On the role of digital tools in nitrosamine risk assessment for drug substance and drug product manufacturing processes;Current Opinion in Chemical Engineering;2024-09

2. Analytical Methodologies to Detect N-Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices;Chemical Research in Toxicology;2024-08-19

3. Water as a green solvent for sustainable sample preparation: single drop microextraction of N-nitrosamines from losartan tablets;Analytical and Bioanalytical Chemistry;2024-08-10

4. Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates;Organic Process Research & Development;2024-07-25

5. Formation of N-Nitrosamines by Reaction of Secondary Dialkylamines with Trace Levels of Nitrite in Aqueous Solution: An Automated Experimental and Kinetic Modeling Study Using Di-n-butylamine;Organic Process Research & Development;2023-12-21

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