(2-Hydroxyethyl)trimethylammonium chloride;
2-Hydroxy-N,N,N-trimethylethanaminium chloride [67-48-1]
BRIEFING
Choline Chloride. This proposal is based on the version of the monograph to be official on August 1, 2026. On the basis of comments received, USP has reverted the monograph to the official version prior to August 1, 2023, as shown in the Notice of Intent to Revise posted to USP–NF: www.uspnf.com/notices/choline-chloride-nitr-20250423. To address the concerns related to the precision of the HPLC method for the Assay procedure in the current official text and to replace the titration-based method to which the procedure has been reverted, the following changes are being proposed:
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Add Identification C based on the retention time agreement as obtained in the Assay.
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Replace the titration-based method for the Assay with a new HPLC-RI method, which is based on analysis performed with a SIELC Primesep 100 brand of column with L85 packing. The typical retention times for choline and choline related compound A peaks are 5.8 and 6.5, respectively.
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Revise the Limit of Total Amines test to correct the plotting instructions and to correct the cumulative concentrations used for the Standard response line.
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Replace the Chromatographic Purity test with the Related Compounds test using the HPLC-CAD method, as previously proposed in PF 47(1).
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(NBDS: F. Tadjimukhamedov)
Case ID—SUB-2793