Pharmeuropa: Revision of Residual Solvents Chapter 2.4.24 Published for Comments

On 30 September 2025, the European Pharmacopoeia published in Pharmeuropa 37.4 a fully revised draft of Chapter 2.4.24 Identification and control of residual solvents for public consultation.

According to the briefing note, the revision is mainly editorial, aiming to improve clarity and usability. Key updates include:

• A clearer distinction between non-targeted and targeted analysis approaches.
• Introduction of a separate system suitability solution prepared from a subset of Class 2 solvents.
• Updated chromatograms for Class 2 residual solvents, now also covering cyclopentyl methyl ether and tert-butyl alcohol.

The updated chapter now follows this structure:

• Introduction
• Principle
• Equipment
• Procedure
• Preparation of solutions
• Identification and confirmation of solvents in the substance to be examined (steps 1 and 2)
• Quantitation of identified or specified residual solvents (step 3 – limit test)

The draft text is available on the Pharmeuropa website (login required). Comments can be submitted until 31 December 2025 via the Pharmeuropa platform.