Choline dihydrogen citrate;
Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1);
(2-Hydroxyethyl)trimethylammonium dihydrogen citrate [77-91-8]
BRIEFING
Choline Citrate. This proposal is based on the version of the monograph official as of August 1, 2022. On the basis of comments received, the following changes are being proposed:
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In the Assay, replace the Content of Choline, Content of Citrate, and Content of Choline Citrate procedures, which used the HPLC-CAD method, with a new single Procedure that uses the HPLC-RI method 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 volumes of water and sodium hydroxide TS in the preparation of the Sample solution and the cumulative concentrations used for the Standard response line.
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Revise the Related Compounds test to include the solution preparation procedures and the HPLC-CAD method details from the omitted Assay procedures.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(NBDS: F. Tadjimukhamedov)
Case ID—SUB-3170
USP REFERENCE STANDARDS FOR PURCHASE
USP Choline Citrate RSUSP Choline Related Compound A RS
USP Citric Acid RS