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.
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. Capsules also meet the requirements of the tests for absence of
Salmonella species,
Escherichia coli, and
Staphylococcus aureus.
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 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 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.