Packaging and storage
Preserve in tight, light-resistant containers.
Labeling*
The label states that the product is Oil- and Water-Soluble Vitamins Tablets. The label also states the quantity of each vitamin per dosage unit and, where necessary, the chemical form in which it is present. Where the product contains vitamin E, the label indicates whether it is the
d- or
dl- form. Where more than one
Assay method is given for a particular vitamin, the labeling states with which
Assay method the product complies only if
Method 1 is not used.
USP Reference standards
11
USP Alpha Tocopherol RS.
USP Alpha Tocopheryl Acetate RS.
USP Alpha Tocopheryl Acid Succinate RS.
USP Biotin RS.
USP Calcium Pantothenate RS.
USP Cholecalciferol RS.
USP Cyanocobalamin RS.
USP Ergocalciferol RS.
USP Folic Acid RS.
USP Niacin RS.
USP Niacinamide RS.
USP Phytonadione RS.
USP Pyridoxine Hydrochloride RS.
USP Riboflavin RS.
USP Thiamine Hydrochloride RS.
USP Vitamin A RS.
Microbial enumeration
2021
The total aerobic microbial count does not exceed 3000 cfu per g, and the combined molds and yeasts count does not exceed 300 cfu per g. Tablets also meet the requirements of the tests for absence of
Salmonella species,
Escherichia coli, and
Staphylococcus aureus.
note
Where more than one
Assay method is given for an individual ingredient, the requirements may be met by following any one of the specified methods, the method used being stated in the labeling only if
Method 1 is not used.
Assay for niacin or niacinamide, pyridoxine hydrochloride, riboflavin, and thiamine, Method 1
Proceed as directed in the
Assay for niacin or niacinamide, pyridoxine hydrochloride, riboflavin, and thiamine, Method 1 under
Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for niacin or niacinamide, pyridoxine hydrochloride, riboflavin, and thiamine, Method 3
Proceed as directed in the
Assay for niacin or niacinamide, pyridoxine hydrochloride, riboflavin, and thiamine, Method 3 under
Oil- and Water-Soluble Vitamins with Minerals Tablets.