BRIEFING

 Levocarnitine Tartrate. A new monograph for this dietary ingredient is being proposed. The HPLC procedure used in the Assay is based on analyses performed with a Waters Xbridge Amide BEH brand of column with L68 packing. The typical retention times for tartaric acid, levocarnitine related compound A, and levocarnitine are about 2.1, 2.6, and 2.9 min, respectively. The HPLC procedure used in the test for Related Compounds is based on analyses performed with an Agilent Zorbax NH2 brand of column with L8 packing. The typical retention times for levocarnitine and levocarnitine related compound A are about 11.3 and 13.3 min, respectively. Lastly, the HPLC procedure used in the test for Enantiomeric Purity is based on analyses performed with a Supelco Astec Chirobiotic TAG brand of column with L63 packing. The typical retention times for levocarnitine, d-carnitine, and levocarnitine related compound A are about 10.1, 14.0, and 15.8 min, respectively.

 This proposal is based on the FCC monograph for l-Carnitine l-Tartrate (effective as of December 1, 2016) as well as data submitted by a manufacturer of this dietary ingredient. Interested parties are encouraged to submit data for the same ingredient derived from other sources or manufacturing processes.

 (NBDS: F. Tadjimukhamedov)

 Correspondence Number—C223852