USP expands its extractables and leachables chapter series with new chapter <1664.5>

USP has published the new general chapter <1664.5> Assessment of Leachables in Oral Drug Products in Pharmacopeial Forum PF 52(5). The chapter addresses the assessment of organic substances migrating from manufacturing equipment and container closure systems into liquid (solutions, suspensions, emulsions, elixirs, syrups), semi-solid (ointments, pastes) and solid (tablets, capsules, powders, granules) oral dosage forms (elemental impurities are governed by ICH Q3D). The same issue carries an explanatory Stimuli article on updating system suitability (SST) mixtures for chromatographic analysis: USP ran an interlaboratory study involving 15 laboratories and optimised the composition of the control mixtures. Comments on the proposal are accepted until 30 November 2026.

This review was prepared for the News section of the journal «Oʻzbekiston farmatsevtik xabarnomasi» (Pharmaceutical Bulletin of Uzbekistan).

Source: doi.usp.org