USP Draft Chapter on Leachables in Oral Drug Products

The USP is expanding the Extractables and Leachables (E&L) chapter series <1664>. Following the publication of four draft chapters addressing E&Ls in various dosage forms, a new chapter, <1664.5> Assessment of Leachables in Oral Drug Products, has now been published in Pharmacopeial Forum PF 52(5). The comment deadline is 30 November 2026.

Background

The new chapter addresses specific considerations for leachables in oral dosage forms (ODFs), including liquids (solutions, suspensions, emulsions, elixirs, and syrups), semisolids and pastes, and solids (tablets, capsules, pills, powders, granules, and premixes). The chapter considers leachables originating from two sources: manufacturing systems used to produce the dosage form and container closure systems used to package the dosage form over its shelf life. It primarily discusses organic leachables. ICH Q3D applies to the assessment of elemental leachables.

In addition, a Stimuli article entitled "Updates to System Suitability Mixtures in Support of Chromatographic Screening for Organic Extractables and Leachables" has been published in the same issue of Pharmacopeial Forum. To facilitate consistent analytical performance across laboratories and standardize system suitability testing, standardized system suitability mixtures are needed. Therefore, fifteen testing laboratories performed a round-robin study to establish the suitability of these mixtures for use. Based on the study results, the compositions of the system suitability mixtures were modified and finalized. The article presents the final standard mixtures and illustrates their chromatographic behavior.

For more information please visit the Pharmacopeial Forum website.