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Approaches to Assessment, Testing Decisions, and Analytical Determination of Genotoxic Impurities in Drug Substances

https://doi.org/10.1021/op8002129
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What this work says

Outgoing claims: the papers this work cites, builds on, or argues with.

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Toxicological overview of impurities in pharmaceutical products☆
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Progress in QSAR toxicity screening of pharmaceutical impurities and other FDA regulated products☆☆☆
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A quality evaluation strategy for multi-sourced active pharmaceutical ingredient (API) starting materials
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Control and analysis of alkyl esters of alkyl and aryl sulfonic acids in novel active pharmaceutical ingredients (APIs)
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Use of 2-mercaptopyridine for the determination of alkylating agents in complex matrices: application to dimethyl sulfate
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Regulation of genotoxic and carcinogenic impurities in drug substances and products
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A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity
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The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development
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Residues of genotoxic alkyl mesylates in mesylate salt drug substances: Real or imaginary problems?
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An impact analysis of the application of the threshold of toxicological concern concept to pharmaceuticals
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Determination of polar alkylating agents as thiocyanate/isothiocyanate derivatives by reaction headspace gas chromatography
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Setting Limits for Genotoxic Impurities in Drug Substances
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Assessment and Acceptance of Thresholds of Genotoxic Impurities in New Drug Substances
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Acceptability of Low Levels of Genotoxic Impurities in New Drug Substances
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Acceptability of Low Levels of Genotoxic Impurities in New Drug Substances

What points at this work

Incoming claims: where this work appears in other papers’ reference lists and arguments.

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Genotoxic Impurity for Degradation Products: The Review
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Mutagenic impurities
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In-Process Control Testing
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Route Selection
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Mutagenic impurities
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Route Design
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Oxidative fluorination of N-arylsulfonamides
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Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process
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Determination and control of TEMPO, a potentially genotoxic free radical reagent used in the synthesis of filibuvir
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Identification, development and determination of genotoxic impurities in Colesevelam hydrochloride drug substance using gas chromatography coupled with mass detector
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A sensitive UPLC-MS/MS method for the simultaneous assay and trace level genotoxic impurities quantification of SARS-CoV-2 inhibitor-Molnupiravir in its pure and formulation dosage forms using fractional factorial design
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Advancing Toxicology-Based Cancer Risk Assessment with Informatics
Editorial review for independent work. ICSAC — the Institute for Complexity Science and Advanced Computing — runs a structured editorial panel for researchers publishing outside journals, and publishes on CiteStamp rails. Submission is free and goes through ORCID: icsacinstitute.org/submit.