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

Recommendation
Wednesday, 1 October 2025 13.00 - 17.00 h
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
30.06.2025FDA Warning Letter: Missing Testing, No Stability Data, and Inadequate Raw Material Controls
25.06.2025FDA Warning Letter: "Memory-Based Manufacturing" and Lack of Analytical Testing
11.06.2025USP informs about Monographs affected by the Revision of NMR Chapters <761> and <1761>
28.05.2025FDA Warning Letter for Chinese Manufacturer: Inadequate Testing and Stability Program Deficiencies