European Pharmacopoeia Publishes Draft Revision on Residual Solvent Testing for Public Consultation

On 30 September 2025, the European Pharmacopoeia released a fully revised draft of Chapter 2.4.24 – Identification and Control of Residual Solvents in Pharmeuropa 37.4 for public consultation. The revision is primarily editorial, aiming to enhance clarity and usability for analytical laboratories.

Key updates include a clearer distinction between non-targeted and targeted analytical approaches, the introduction of a separate system suitability solution derived from a subset of Class 2 solvents, and updated chromatograms covering additional solvents such as cyclopentyl methyl ether and tert-butyl alcohol.

The chapter is now structured to guide users through introduction, principle, equipment, procedure, solution preparation, identification and confirmation of solvents, and quantitation/limit testing.

The draft is accessible via the Pharmeuropa website (login required), with comments invited until 31 December 2025 through the platform, enabling stakeholders to provide input before the final version is published.

06-10-2025