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Minerals Tablets
» Minerals Tablets contain two or more minerals derived from substances generally recognized as safe, furnishing two or more of the following elements in ionizable form: calcium, chromium, copper, fluorine, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, and zinc. Tablets contain not less than 90.0 percent and not more than 125.0 percent of the labeled amounts of calcium (Ca), copper (Cu), iron (Fe), magnesium (Mg), manganese (Mn), phosphorus (P), potassium (K), and zinc (Zn), and not less than 90.0 percent and not more than 125.0 percent of the labeled amounts of chromium (Cr), fluorine (F), iodine (I), molybdenum (Mo), and selenium (Se). They contain no vitamins. They may contain other labeled added substances in amounts that are unobjectionable.
Packaging and storage— Preserve in tight, light-resistant containers.
Labeling— The label states that the product is Minerals Tablets. The label also states the salt form of the mineral used as the source of each element. Where more than one Assay method is given for a particular mineral, the labeling states the Assay method used only if Method 1 is not used.
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.
Disintegration and dissolution 2040: meet the requirements for Dissolution.
Weight variation 2091: meet the requirements.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
NOTE— In the following Assays, 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. Commercially available atomic absorption standard solutions for the minerals, where applicable, may be used where preparation of a standard stock solution is described in the following Assays. Use deionized water where water is specified. Where atomic absorption spectrophotometry is specified in the Assay, the concentrations of the Standard preparations and the Assay preparation may be modified to fit the linear or working range of the instrument.
Assay for calcium— Proceed as directed in the Assay for calcium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for chromium— Proceed as directed in the Assay for chromium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for copper— Proceed as directed in the Assay for copper under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for fluoride, Method 1— Proceed as directed in the Assay for fluoride, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for fluoride, Method 2— Proceed as directed in the Assay for fluoride, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for iodide, Method 1— Proceed as directed in the Assay for iodide, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for iodide, Method 2— Proceed as directed in the Assay for Iodide under Automated Methods of Analysis 16.
Assay for iron— Proceed as directed in the Assay for iron under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for magnesium— Proceed as directed in the Assay for magnesium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for manganese— Proceed as directed in the Assay for manganese under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for molybdenum, Method 1— Proceed as directed in the Assay for molybdenum, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for molybdenum, Method 2— Proceed as directed in the Assay for molybdenum, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for phosphorus— Proceed as directed in the Assay for phosphorus under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for potassium— Proceed as directed in the Assay for potassium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for selenium, Method 1— Proceed as directed in the Assay for selenium, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for selenium, Method 2— Proceed as directed in the Assay for selenium, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for zinc— Proceed as directed in the Assay for zinc under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Auxiliary Information— Staff Liaison : Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 2367
Pharmacopeial Forum : Volume No. 28(5) Page 1543
Phone Number : 1-301-816-8389