BRIEFING
Calcium with Vitamin D Chewable Gels. A new USP monograph for this dietary supplement dosage form is being proposed.
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The liquid chromatographic procedure for the Strength assay for Vitamin D (Cholecalciferol), Method 1 is based on analyses performed with the 25-cm × 4.6-mm Hypersil-C18 brand of column with L1 packing. The approximate retention times for ergocalciferol and cholecalciferol are 12.6 and 13.4 min, respectively.
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The liquid chromatographic procedure for the Strength assay for Vitamin D (Cholecalciferol), Method 2 is based on analyses performed with the 25-cm × 4.6-mm Partisil brand of column with L3 packing. The approximate retention time for cholecalciferol is 10 min.
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The liquid chromatographic procedure for the two tests for vitamin D (cholecalciferol) in the Disintegration and Dissolution test is based on analyses performed with the 3-mm × 15-cm Ultimate AQ-C18 brand of column with L1 packing. The approximate retention time for cholecalciferol is 12.5 min.
(NBDS: N. Davydova)
Case ID—SUB-433