BRIEFING

 Oil-Soluble Vitamins Capsules. This proposal is based on the version of the monograph official as of November 1, 2023. The following changes are being proposed:

1. Add a new alternative analytical procedure for the simultaneous determination of vitamins A, E, D, and K1 (phytonadione). The liquid chromatographic procedure is based on analyses performed with the Waters Acquity BEH Shield RP C18 brand of column with L1 packing. The typical retention times for retinyl acetate, ergocalciferol, cholecalciferol, tocopheryl succinate, tocopherol, tocopheryl acetate, phytonadione, beta carotene, and retinyl palmitate are approximately 4.3, 9.7, 9.9, 11.4, 13.9, 14.4, 15.5, 19.2, and 19.6 min, respectively.

2. Add an Identification section, and add clarifications to the Definition, Strength, and Labeling sections.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (NBDS: N. Davydova)

 Case ID—SUB-225