Water-Soluble Vitamins with Minerals Capsules
» Water-Soluble Vitamins with Minerals Capsules contain one or more of the following water-soluble vitamins: Ascorbic Acid or its equivalent as Calcium Ascorbate or Sodium Ascorbate, Biotin, Cyanocobalamin, Folic Acid, Dexpanthenol or Panthenol, Pantothenic Acid (as Calcium Pantothenate or Racemic Calcium Pantothenate), Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine Hydrochloride or Thiamine Mononitrate; and one mineral or more, furnishing one or more of the following elements in ionizable form: calcium, chromium, copper, fluorine, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, and zinc, derived from substances generally recognized as safe. Capsules contain not less than 90.0 percent and not more than 150.0 percent of the labeled amounts of ascorbic acid (C6H8O6) or its salts as calcium ascorbate (C12H14CaO12·2H2O) or sodium ascorbate (C6H7NaO6), biotin (C10H16N2O3S), cyanocobalamin (C63H88CoN14O14P), folic acid (C19H19N7O6), dexpanthenol (C9H19NO4) or panthenol (C9H19NO4), calcium pantothenate (C18H32CaN2O10), niacin (C6H5NO2) or niacinamide (C6H6N2O), pyridoxine hydrochloride (C8H11NO3·HCl), riboflavin (C17H20N4O6), and thiamine (C12H17ClN4OS) as thiamine hydrochloride or thiamine mononitrate; 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 do not contain any form of Beta Carotene or Vitamin A, D, E, or K. They may contain other labeled added substances that are generally recognized as safe, in amounts that are unobjectionable.
Packaging and storage— Preserve in tight, light-resistant containers.
Labeling— The label states that the product is Water-Soluble Vitamins with Minerals Capsules. The label also states the quantity of each vitamin and mineral in terms of metric units per dosage unit and where necessary the chemical form in which a vitamin is present and 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 vitamin or mineral, the labeling states with which Assay method the product complies only if Method 1 is not used.
USP Reference standards 11—
USP Biotin RS.
USP Calcium Pantothenate RS.
USP Cyanocobalamin RS.
USP Dexpanthenol RS.
USP Folic Acid RS.
USP Niacin RS.
USP Niacinamide RS.
USP Pyridoxine Hydrochloride RS.
USP Riboflavin RS.
USP Sodium Fluoride RS.
USP Thiamine Hydrochloride 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. Capsules 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.
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.
Assay for ascorbic acid, Method 1— Accurately weigh not fewer than 20 Capsules in a tared weighing bottle. Using a sharp blade if necessary, carefully cut open the Capsules, without the loss of shell material, and transfer the contents to a 100-mL beaker. Remove any contents adhering to the empty shells by washing if necessary with several portions of ether. Discard the washings, and dry the Capsule shells with the aid of a current of dry air until the odor of ether is no longer perceptible. Weigh the empty Capsule shells in the tared weighing bottle, and calculate the average net weight per Capsule. Transfer an accurately weighed portion of the Capsule contents, equivalent to about 100 mg of ascorbic acid, to a 200-mL volumetric flask, and proceed as directed in the Assay for ascorbic acid, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets, beginning with “add about 75 mL of metaphosphoric-acetic acids TS” and calculating the content of ascorbic acid in each Capsule.
Assay for ascorbic acid, Method 2— Proceed as directed in the Assay for Ascorbic Acid under Automated Methods of Analysis 16.
Assay for calcium ascorbate, Method 1— Proceed as directed in the Assay for ascorbic acid, Method 1.
Assay for calcium ascorbate, Method 2— Proceed as directed in the Assay for Ascorbic Acid under Automated Methods of Analysis 16.
Assay for sodium ascorbate, Method 1— Proceed as directed in the Assay for ascorbic acid, Method 1.
Assay for sodium ascorbate, Method 2— Proceed as directed in the Assay for Ascorbic Acid under Automated Methods of Analysis 16.
Assay for biotin, Method 1— Proceed as directed in the Assay for biotin, 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— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 1 mg of biotin, to a 200-mL volumetric flask. Add 3 mL of dimethyl sulfoxide, and swirl to wet the contents. Place the flask in a water bath at 60 to 70 for 5 minutes. Sonicate for 5 minutes, dilute with water to volume, mix, and filter.
Assay for biotin, Method 2— Proceed as directed in the Assay for biotin, 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— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 100 µg of biotin, to a 200-mL volumetric flask, add 3 mL of 50 percent alcohol, and swirl to wet the contents. Heat the flask in a water bath at 60 to 70 for 5 minutes. Sonicate for 5 minutes, dilute with water to volume, mix, and filter. Dilute an accurately measured volume of the filtrate quantitatively, and stepwise if necessary, with diluted alcohol to obtain a solution having a concentration of about 0.1 ng per mL.
Assay for cyanocobalamin, Method 1— Proceed as directed in the Assay for cyanocobalamin, 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— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 100 µg of cyanocobalamin, to a 250-mL flask. Quantitatively add 100.0 mL of water, and carefully extract for 2 minutes. Filter about 10 mL of the extract, and use the clear solution.
Assay for cyanocobalamin, Method 2— Proceed as directed in the Assay for cyanocobalamin, 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— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 1.0 µg of cyanocobalamin, to an appropriate vessel containing, for each g of Capsule contents taken, 25 mL of an aqueous extracting solution prepared just prior to use to contain, in each 100 mL, 1.29 g of dibasic sodium phosphate, 1.1 g of anhydrous citric acid, and 1.0 g of sodium metabisulfite. Autoclave the mixture at 121 for 10 minutes. Allow any undissolved particles of the extract to settle, and filter or centrifuge if necessary. Dilute an aliquot of the clear solution with water to obtain a final solution containing vitamin B12 activity approximately equivalent to that of the Standard preparation.
Assay for folic acid, Method 1— Proceed as directed in the Assay for folic acid, 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— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 0.4 mg of folic acid, to a 50-mL centrifuge tube. Add 25.0 mL of Internal standard preparation, insert a stopper, shake by mechanical means for 10 minutes, and centrifuge. Filter a portion of the clear supernatant, and use the filtrate.
Assay for folic acid, Method 2— Proceed as directed in the Assay for folic acid, Method 2 under Water-Soluble Vitamins Tablets, except to read Capsules in place of Tablets and to use the following Assay preparation.
Assay preparation— Proceed as directed for Assay preparation in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 0.3 mg of folic acid, to a stoppered 125-mL flask. Add 10.0 mL of a mixture of methanol and glacial acetic acid (9:1) and 30 mL of a mixture of methanol and ethylene glycol (1:1), insert the stopper, shake for 15 minutes in a water bath maintained at 60, and cool. Filter, discarding the first few mL of the filtrate.
Assay for dexpanthenol or panthenol— Proceed as directed in the Assay for dexpanthenol or panthenol under Water-Soluble Vitamins Capsules.
Assay for calcium pantothenate, Method 1— Proceed as directed in the Assay for calcium pantothenate, 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— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 15 mg of calcium pantothenate, to a centrifuge tube. Transfer 25.0 mL of the Internal standard preparation to the centrifuge tube, and shake vigorously for 10 minutes. Centrifuge, filter, and use the clear filtrate.
Assay for calcium pantothenate, Method 2— Proceed as directed in the Assay for calcium pantothenate, 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— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 50 mg of calcium pantothenate, to a 1000-mL volumetric flask containing 500 mL of water. Add 10 mL of 0.2 N acetic acid and 100 mL of sodium acetate solution (1 in 60), dilute with water to volume, and filter. Dilute an accurately measured volume of this solution quantitatively, and stepwise if necessary, to obtain a solution having about the same concentration as that of the Standard preparation.
Assay for calcium pantothenate, Method 3— Proceed as directed in the Assay for calcium pantothenate, Method 3 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— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 10 mg of calcium pantothenate, to a 250-mL volumetric flask, add 10 mL of methanol, and swirl the flask to disperse the Capsule contents. Dilute with water to volume, mix, and filter.
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, except to read Capsules in place of Tablets and to use the following Assay preparation.
Assay preparation— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 10 mg of niacinamide and 2.5 mg each of pyridoxine hydrochloride, riboflavin, and thiamine hydrochloride, to a 50-mL centrifuge tube. Add 25.0 mL of Diluting solution, and mix, using a vortex mixer, for 30 seconds to completely suspend the powder. Immerse the centrifuge tube in a hot water bath maintained at 65 to 70, heat for 5 minutes, and mix, using a vortex mixer, for 30 seconds. Return the tube to the hot water bath, heat for another 5 minutes, and mix, using a vortex mixer, for 30 seconds. Filter a portion of the solution, cool to room temperature, and use the clear filtrate. [note—Use the filtrate within 3 hours after filtration.]
Assay for niacin, Method 2— Proceed as directed in the Assay for niacin, 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— [note—This preparation is suitable for the determination of niacin or niacinamide, pyridoxine hydrochloride, and riboflavin, when present in the formulation.] 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 beaker. Remove any contents adhering to the 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 2 mg of riboflavin, to a 250-mL volumetric flask. If riboflavin is not present in the formulation, use a portion equivalent to about 2 mg of pyridoxine. If pyridoxine is not present in the formulation, use a portion equivalent to about 20 mg of niacin or niacinamide. Add 100.0 mL of Extraction solvent, and mix for 20 minutes, using a wrist-action shaker. Immerse the flask in a water bath maintained at 70 to 75, and heat for 20 minutes. Mix on a vortex mixer for 30 seconds, cool to room temperature, and filter. Use the clear filtrate.
Assay for niacinamide, Method 2— Proceed as directed in the Assay for niacinamide, 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— Prepare as directed for Assay preparation in the Assay for niacin, Method 2.
Assay for pyridoxine hydrochloride, Method 2— Proceed as directed in the Assay for pyridoxine hydrochloride, 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— Prepare as directed for Assay preparation in the Assay for niacin, Method 2.
Assay for riboflavin, Method 2— Proceed as directed in the Assay for riboflavin, 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— Prepare as directed for Assay preparation in the Assay for niacin, Method 2.
Assay for thiamine, Method 2— Proceed as directed in the Assay for thiamine, 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— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the contents, equivalent to about 2 mg of thiamine, to a 250-mL volumetric flask. Add 100.0 mL of 0.2 N hydrochloric acid, shake for 15 minutes with a wrist-action shaker, and heat to boiling for 30 minutes. Cool to room temperature, filter, and use the clear filtrate.
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, except to read Capsules in place of Tablets and to use the following Assay preparation.
Assay preparation— Proceed as directed in the Assay for ascorbic acid, Method 1, through “calculate the average net weight per Capsule.” Transfer an accurately weighed portion of the Capsule contents, equivalent to about 7.5 mg of niacin or niacinamide, 1.2 mg of pyridoxine hydrochloride, 0.4 mg of riboflavin, and 1.2 mg of thiamine hydrochloride, to a stoppered 125-mL flask. Add 10.0 mL of a mixture of methanol and glacial acetic acid (9:1) and 30.0 mL of a mixture of methanol and ethylene glycol (1:1). Insert the stopper, shake for 15 minutes in a water bath maintained at 60, and cool. Filter, discarding the first few mL of the filtrate.
note—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 Standard preparations and the Assay preparation may be diluted quantitatively with the solvent specified, if necessary, to yield solutions of suitable concentrations adaptable to 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. [note—For 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 the Capsules, 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 the Capsules, 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 for Procedure in the Assay for iodide, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets, beginning with “Add 5 g of sodium carbonate.”
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 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 the Capsules, 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 the Capsules, 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 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 about 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 the Capsules, 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 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 the Capsules, 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 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.
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Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.