Minerals Capsules
» Minerals Capsules 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. Capsules 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 160.0 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 Capsules. 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.
USP Reference standards
![]() ![]() USP Sodium Fluoride RS.
Microbial enumeration
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Disintegration and dissolution
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Weight variation
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Assay for calcium
Proceed as directed in the Assay for calcium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Polysorbate 80 solution and Assay preparation.
Polysorbate 80 solution
Dilute 100 mL of polysorbate 80 with alcohol to 1000 mL.
Assay preparation
Transfer 5 Capsules to a 100-mL volumetric flask. [noteFor hard gelatin Capsules, accurately weigh not fewer than 20 Capsules. Using a sharp blade if necessary, carefully open the Capsules, without loss of shell material, and transfer the contents to a suitable container. Remove any contents adhering to the empty shells by washing with several portions of ether. Discard the washings, and allow the Capsule shells to dry. Weigh the empty Capsule shells, calculate the net weight of the Capsule contents, and transfer an accurately weighed portion of the Capsule contents, equivalent to about 5 Capsules, to a 100-mL volumetric flask.] Add about 15 mL of water, 10 mL of 6 N hydrochloric acid, and about 1 mL of Polysorbate 80 solution to the flask, and heat on a hot plate or steam bath, with intermittent swirling, until the Capsules are completely disintegrated or the contents are dissolved. Boil gently for an additional 15 minutes. Cool, dilute with water to volume, and filter, discarding the first 5 mL of the filtrate. Dilute this solution quantitatively, and stepwise if necessary, with 0.125 N hydrochloric acid to obtain a solution having a known concentration of about 2 µg of calcium per mL, adding 1 mL of Lanthanum chloride solution per 100 mL of the final volume.
Assay for chromium
Proceed as directed in the Assay for chromium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Polysorbate 80 solution and Assay preparation.
Polysorbate 80 solution
Prepare as directed in the Assay for calcium.
Assay preparation
Proceed as directed for Assay preparation in the Assay for calcium, except to prepare the Assay preparation to contain about 1 µg of chromium per mL and to omit the use of the Lanthanum chloride solution.
Assay for copper
Proceed as directed in the Assay for copper under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Polysorbate 80 solution and Assay preparation.
Polysorbate 80 solution
Prepare as directed in the Assay for calcium.
Assay preparation
Proceed as directed for Assay preparation in the Assay for calcium, except to prepare the Assay preparation to contain about 2 µg of copper per mL and to omit the use of the Lanthanum chloride solution.
Assay for fluoride, Method 1
Proceed as directed in the Assay for fluoride, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Assay preparation.
Assay preparation
Remove the contents of a counted number of Capsules by cutting open, using a sharp blade if necessary. Mix, and determine the weight of the contents. Transfer an accurately weighed quantity of the contents, equivalent to about 200 µg of fluoride, to a 100-mL volumetric flask. Add 10.0 mL of 1 N hydrochloric acid, 25.0 mL of 3 M Sodium acetate solution, and 25.0 mL of Sodium citrate solution, dilute with water to volume, and mix.
Assay for fluoride, Method 2
Proceed as directed in the Assay for fluoride, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Assay preparation.
Assay preparation
Accurately weigh not fewer than 20 Capsules in a tared weighing bottle. Using a sharp blade if necessary, carefully open the Capsules, without loss of shell material, and transfer the contents to a 100-mL container. If necessary, remove any contents adhering to the empty shells by washing with several portions of ether. Discard the washings, and dry the Capsule shells with the aid of a current of dry air. Weigh the empty Capsule shells in the tared weighing bottle, and calculate the net weight of the Capsule contents. Transfer an accurately weighed portion of the Capsule contents, equivalent to about 1 mg of fluoride, to a 100-mL volumetric flask. Proceed as directed for Assay preparation in the Assay for fluoride, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets, beginning with add 15 mL of water.
Assay for iodide, Method 1
Bromine water
To about 20 mL of bromine in a glass-stoppered bottle, add 100 mL of water. Insert the stopper into the bottle, and shake. Allow to stand for 30 minutes, and use the supernatant layer.
Procedure
Remove the contents of a counted number of Capsules by cutting open, using a sharp blade if necessary. Mix, and determine the weight of the contents. Transfer an accurately weighed quantity of the contents, equivalent to about 3 mg of iodine, to a nickel crucible. Proceed as directed in the Assay for iodide, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets, beginning with Add about 5 g of sodium carbonate.
Assay for iodide, Method 2
Proceed as directed in the Assay for Iodide under Automated Methods of Analysis
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Assay for iron
Proceed as directed in the Assay for iron under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Polysorbate 80 solution and Assay preparation.
Polysorbate 80 solution
Prepare as directed in the Assay for calcium.
Assay preparation
Proceed as directed for Assay preparation in the Assay for calcium, except to prepare the Assay preparation to contain about 5 µg of iron per mL and to omit the use of the Lanthanum chloride solution.
Assay for magnesium
Proceed as directed in the Assay for magnesium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Polysorbate 80 solution and Assay preparation.
Polysorbate 80 solution
Prepare as directed in the Assay for calcium.
Assay preparation
Proceed as directed for Assay preparation in the Assay for calcium, except to prepare the Assay preparation to contain about 0.4 µg of magnesium per mL.
Assay for manganese
Proceed as directed in the Assay for manganese under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Polysorbate 80 solution and Assay preparation.
Polysorbate 80 solution
Prepare as directed in the Assay for calcium.
Assay preparation
Proceed as directed for Assay preparation in the Assay for calcium, except to prepare the Assay preparation to contain about 1 µg of manganese per mL and to omit the use of the Lanthanum chloride solution.
Assay for molybdenum, Method 1
Proceed as directed in the Assay for molybdenum, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Polysorbate 80 solution and Assay preparation.
Polysorbate 80 solution
Prepare as directed in the Assay for calcium.
Assay preparation
Proceed as directed for Assay preparation in the Assay for calcium, except to take a number of Capsules or a portion of Capsule contents, equivalent to about 1000 µg of molybdenum, and to make appropriate dilutions to obtain a final concentration of about 10 µg of molybdenum per mL, omitting the addition of the Lanthanum chloride solution.
Assay for molybdenum, Method 2
Proceed as directed in the Assay for molybdenum, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Procedure.
Procedure
Remove the contents of a counted number of Capsules by cutting open, using a sharp blade if necessary. Mix, and determine the weight of the contents. Transfer an accurately weighed quantity of the Capsule contents, equivalent to about 40 µg of molybdenum, to a 200-mL beaker, marked I. Proceed as directed for Procedure in the Assay for molybdenum, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets, beginning with To another 200-mL beaker, except to read Capsules in place of Tablets.
Assay for phosphorus
Proceed as directed in the Assay for phosphorus under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Assay preparation.
Assay preparation
Remove the contents of a counted number of Capsules by cutting open, using a sharp blade if necessary, mix, and determine the weight of the contents. Transfer an accurately weighed quantity of the contents, equivalent to about 100 mg of phosphorus, to a suitable flask. Proceed as directed for Assay preparation in the Assay for phosphorus under Oil- and Water-Soluble Vitamins with Minerals Tablets, beginning with add 25 mL of nitric acid.
Assay for potassium
Proceed as directed in the Assay for potassium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Polysorbate 80 solution and Assay preparation.
Polysorbate 80 solution
Prepare as directed in the Assay for calcium.
Assay preparation
Proceed as directed for Assay preparation in the Assay for calcium, except to prepare the Assay preparation to contain 1 µg of potassium per mL and to omit the use of the Lanthanum chloride solution.
Assay for selenium, Method 1
Proceed as directed in the Assay for selenium, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Assay preparation.
Assay preparation
Remove the contents of a counted number of Capsules by cutting open, using a sharp blade if necessary. Mix, and determine the weight of the contents. Transfer an accurately weighed portion of the Capsule contents, equivalent to about 1000 µg of selenium, to a suitable flask. Proceed as directed for Assay preparation in the Assay for selenium, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets, beginning with and add about 12 mL of nitric acid.
Assay for selenium, Method 2
Proceed as directed in the Assay for selenium, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Assay preparation.
Assay preparation
Remove the contents of a counted number of Capsules by cutting open, using a sharp blade if necessary. Mix, and determine the weight of the contents. Transfer an accurately weighed portion of the contents, equivalent to about 20 µg of selenium, to a suitable flask. Proceed as directed for Assay preparation in the Assay for selenium, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets, beginning with Add 10 mL of nitric acid.
Assay for zinc
Proceed as directed in the Assay for zinc under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to read Capsules in place of Tablets and to use the following Polysorbate 80 solution and Assay preparation.
Polysorbate 80 solution
Prepare as directed in the Assay for calcium.
Assay preparation
Proceed as directed for Assay preparation in the Assay for calcium, except to prepare the Assay preparation to contain about 2 µg of zinc per mL and to omit the use of the Lanthanum chloride solution.
Auxiliary Information
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USP32NF27 Page 1057
Pharmacopeial Forum: Volume No. 34(6) Page 1493
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