References and supporting materials for ”ICH Q3C - Residual Solvents: current status”

References 

  1. ICH Q3C(R9). Impurities: Guideline for Residual Solvents. Current Step 4 version, dated 24 January 2024.  

  1. ICH Q3D(R2). Guideline for Elemental Impurities. Final version, Adopted on 26 April 2022.  

  1. ICH M7(R2) Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. Final version. Adopted on 3 April 2023 

  1. Elder DP, Teasdale A. Is Avoidance of Genotoxic Intermediates/Impurities Tenable for Complex, Multistep Syntheses? Org. Process Res. Dev. 2015; 19(11): 1437–1446.   

  1. Fillon YA, Akhtar N, Andrews BI, et al. Determination of Purge Factors for Use in Oligonucleotide Control Strategies. Org Process Res Dev. 2022; 26(4): 1130–1144. 

  1. Parris P, Duncan JN, Fleetwood A, Beierschmitt WP. Calculation Of A Permitted Daily Exposure Value For The Solvent 2-Methyltetrahydrofuran. Regul Toxicol Pharmacol. 2017; 87: 54-63.  

  1. 2-MeTHF was included in ICH Q3C(R8), issued on 22 April 2021.  

  1. Aycock DF. Solvent Applications of 2-Methyltetrahydrofuran in Organometallic and Biphasic Reactions. Org Process Res Dev. 2007; 11(1): 156–159. 

  1. Ferrara M, Negra FD, Verzini M. Solvent Eco-Impact Metric: A Tool for Chemists to Drive Sustainability in Chemical Processes across Safety, Health, Waste, and Environmental Aspects. Org Process Res De. 2025; 29(4): 1110-1124.  

  1. Bercu J, Berlam SC, Berridge J, et al. Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities. J Pharm Innov. 2019; 14, 76-89. 

  1. ICH Q6A specifications: Test Procedures And Acceptance Criteria For New Drug Substances and New Drug Products: Chemical Substances. Current Step 4 version, dated 6 October 1999 

  1. Elder DP. Interpreting ICH’s Evolving Residual Solvents Guideline. Eur Pharm Rev. 2016; 21(5): 30-33.