BRIEFING

 Water-Soluble Vitamins Chewable Gels. A new USP monograph for this dietary supplement dosage form is being proposed.

1. The liquid chromatographic procedure for Ascorbic Acid, Method 1 is based on analyses performed with the Zorbax SB-C8 brand of 4.6-mm × 15-cm column with L7 packing of 3.5-µm particle size. The typical retention time for ascorbic acid is about 3.5 min.

2. The liquid chromatographic procedure for Niacinamide and Pyridoxine, Method 1 is based on analyses performed with the Ultimate AQ brand of 4.6-mm × 15-cm column with L1 packing of 5-µm particle size. The typical retention times for niacinamide and pyridoxine are about 3.0 and 4.5, respectively.

3. The liquid chromatographic procedure for Folic Acid, Method 1 is based on analyses performed with the Diamonsil Plus brand of 4.6-mm × 25-cm column with L7 packing of 5-µm particle size. The typical retention time for folic acid is about 6.5 min.

4. The liquid chromatographic procedure for Riboflavin and Thiamine, Method 1; Ascorbic Acid, Niacinamide, Pyridoxine, and Folic Acid, Method 2 is based on analyses performed with the Inertsil ODS 3V brand of 4.6-mm × 15-cm column with L1 packing of 5-µm particle size. The typical retention times for thiamin, ascorbic acid, niacinamide, pyridoxine, folic acid, and riboflavin are about 2.5, 3.4, 4.7, 6.6, 16.0, and 18.3, respectively.

5. The liquid chromatographic procedure for Cyanocobalamin is based on analyses performed with the Zorbax Eclipse brand of 4.6-mm × 15-cm column with L1 packing of 3.5-µm particle size. The typical retention time for cyanocobalamin is about 14 min.

6. The liquid chromatographic procedure for Biotin is based on analyses performed with the Zorbax Eclipse brand of 4.6-mm × 15-cm column with L7 packing of 3.5-µm particle size. The typical retention time for biotin is about 9.5 min.

 (NBDS: N. Davydova)

 Case ID—SUB-1970