USP Draft Chapter on HPTLC Identification of Fixed Oils published for Comments
Recommendation

Thursday, 3 September 2026 9 .00 - 17.00 h
Establishment, Use and Maintenance of Analytical Reference Substances
In the Pharmacopeial Forum, PF 50(5), a proposal for a revised USP General Chapter <202> Identification of Fixed Oils by Thin-Layer Chromatography has been published for comments. The procedure is used to identify fixed oils using high-performance thin-layer chromatography (HPTLC), with a suitable octadecylsilyl silica gel as the coating substance.
According to the briefing notes, in addition to minor editorial changes, the following changes are proposed:
- "Add Method III to include a method that utilizes a more environmentally friendly solvent, a more environmentally friendly derivatization reagent, and the latest generation of high-performance thin-layer chromatography reverse-phase plates.
- Add USP Black Cumin Seed Oil RS, USP Castor Oil RS, USP Chia Seed Oil RS, USP Coix Seed Oil Extract RS, USP Hydrogenated Castor Oil RS, USP Krill Oil RS, USP Oleic Acid RS, and USP Triolein RS to the USP Reference Standards section."
The draft of the revised chapter is available on PF Online. The comment period is open from now on until 30 November 2024.
Related GMP News
17.08.2026FDA Warning Letter: Averaging Data to Override OOS Findings
12.08.2026ECA's Analytical Control Group Publishes Detailed Report on OOS Survey
12.08.2026BP Publishes Key Insights on Limits in Chromatographic Tests
04.08.2026BioPhorum Publishes a Roadmap for QC Sample Test Execution
04.08.2026USP AISQ Virtual Workshop: ECA AQCG Board Members Contributed as Speakers
04.08.2026Several FDA Warning Letters and Untitled Letters on Asbestos Testing of Talc in OTC Drug Products


