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 90.0percent and not more than 125.0percent 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 90.0percent and not more than 125.0percent 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 Assaymethod is given for a particular mineral,the labeling states the Assaymethod used only if Method 1is not used.
Microbial enumeration á2021ñ— The total aerobic microbial count does not exceed 3000cfu per g,and the combined molds and yeasts count does not exceed 300cfu per g.Tablets also meet the requirements of the tests for absence of Salmonellaspecies,Escherichia coli,and Staphylococcus aureus.
Disintegration and dissolution á2040ñ: meet the requirements for Dissolution.
Weight variation á2091ñ: meet the requirements.
NOTE—In the following Assays,where more than one Assaymethod 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 1is 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 preparationsand the Assay preparationmay be modified to fit the linear or working range of the instrument.
Assay for calcium— Proceed as directed in the Assay for calciumunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation.
Assay for chromium— Proceed as directed in the Assay for chromiumunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation.
Assay for copper— Proceed as directed in the Assay for copperunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation.
Assay for fluoride,Method 1— Proceed as directed in the Assay for fluoride,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for fluoride,Method 2— Proceed as directed in the Assay for fluoride,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for iodide,Method 1— Proceed as directed in the Assay for iodide,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for iodide,Method 2— Proceed as directed in the Assay for Iodideunder Automated Methods of Analysis á16ñ.
Assay for iron— Proceed as directed in the Assay for ironunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation.
Assay for magnesium— Proceed as directed in the Assay for magnesiumunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation.
Assay for manganese— Proceed as directed in the Assay for manganeseunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation.
Assay for molybdenum,Method 1— Proceed as directed in the Assay for molybdenum,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for molybdenum,Method 2— Proceed as directed in the Assay for molybdenum,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for phosphorus— Proceed as directed in the Assay for phosphorusunder Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for potassium— Proceed as directed in the Assay for potassiumunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation.
Assay for selenium,Method 1— Proceed as directed in the Assay for selenium,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for selenium,Method 2— Proceed as directed in the Assay for selenium,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for zinc— Proceed as directed in the Assay for zincunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 2120
Pharmacopeial Forum:Volume No.28(5)Page 1543
Phone Number:1-301-816-8389