Calcium and Vitamin D with Minerals Tablets
DEFINITION
Calcium and Vitamin D with Minerals Tablets contain Vitamin D as Ergocalciferol (Vitamin D2) or Cholecalciferol (Vitamin D3), Calcium, and one or more minerals derived from substances generally recognized as safe, furnishing one or more of the following elements in ionizable form: copper, magnesium, manganese, and zinc. Tablets contain NLT 90.0% and NMT 165.0% of the labeled amount of vitamin D, as cholecalciferol (C27H44O) or ergocalciferol (C28H44O), and NLT 90.0% and NMT 125.0% of the labeled amounts of calcium (Ca), copper (Cu), magnesium (Mg), manganese (Mn), and zinc (Zn). They may contain other labeled added substances that are generally recognized as safe, in amounts that are unobjectionable.
STRENGTH
• Cholecalciferol or Ergocalciferol (Vitamin D)
[Note—Use low-actinic glassware throughout this procedure. ]
Mobile phase:
n-Hexane and isopropyl alcohol (99:1)
Standard solution:
2 µg/mL of USP Ergocalciferol RS or USP Cholecalciferol RS in n-hexane
System suitability solution:
Heat a volume of Standard solution at 60
for 1 h to partially isomerize vitamin D (ergocalciferol or cholecalciferol) to its corresponding precursor.
for 1 h to partially isomerize vitamin D (ergocalciferol or cholecalciferol) to its corresponding precursor.
Sample solution:
Weigh NLT 20 Tablets, and grind the Tablets to a fine powder. Transfer the equivalent of 20 µg of cholecalciferol or ergocalciferol to a container having a polytef-lined screw cap. Add 8 mL of dimethyl sulfoxide and 12 mL of n-hexane, and shake for 45 min on a wrist-action shaker with tubes in a water bath maintained at 60. Centrifuge for 10 min, withdraw the hexane layer by means of a pipet, and transfer to an evaporation flask. Add 12 mL of n-hexane to the dimethyl sulfoxide layer, mix on a vortex mixer for 5 min, and again withdraw the hexane layer by means of a pipet, and add to the evaporation flask. Repeat this extraction with three additional 12-mL portions of n-hexane, adding the hexane extracts to the evaporation flask. Evaporate the combined hexane extracts in vacuum at room temperature to dryness. Dissolve in and dilute the residue in a volume of n-hexane to obtain a concentration of 2 µg/mL.
. Centrifuge for 10 min, withdraw the hexane layer by means of a pipet, and transfer to an evaporation flask. Add 12 mL of n-hexane to the dimethyl sulfoxide layer, mix on a vortex mixer for 5 min, and again withdraw the hexane layer by means of a pipet, and add to the evaporation flask. Repeat this extraction with three additional 12-mL portions of n-hexane, adding the hexane extracts to the evaporation flask. Evaporate the combined hexane extracts in vacuum at room temperature to dryness. Dissolve in and dilute the residue in a volume of n-hexane to obtain a concentration of 2 µg/mL.
Chromatographic system
Mode:
LC
Detector:
UV 265 nm
Column:
4.6-mm × 15-cm; 5-µm packing L8
Flow rate:
1 mL/min
Injection size:
100 µL
System suitability
Samples:
Standard solution and System suitability solution
Suitability requirements
Resolution:
NLT 10 between the vitamin D form present and its corresponding precursor, System suitability solution
Relative standard deviation:
NMT 3.0%, Standard solution
Analysis
Samples:
Standard solution and Sample solution
Measure the responses for the vitamin D peaks. Calculate the percentage of the labeled amount of cholecalciferol (C27H44O) or ergocalciferol (C28H44O) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × F × 100
| rU | = | = peak height for cholecalciferol or ergocalciferol from the Sample solution |
| rS | = | = peak height for cholecalciferol or ergocalciferol from the Standard solution |
| CS | = | = concentration of USP Ergocalciferol RS or USP Cholecalciferol RS in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of ergocalciferol or cholecalciferol in the Sample solution (µg/mL) |
| F | = | = correction factor to account for the average amount of previtamin D present in the Sample solution, 1.09 |
Acceptance criteria:
90.0%–165.0% of the labeled amount of cholecalciferol (C27H44O) or ergocalciferol (C28H44O)
• Calcium, Method 1
[Note—A commercially available atomic absorption standard solution for calcium may be used where preparation of a Calcium standard stock solution is described in the following section. Concentrations of the Standard solutions and the Sample stock solution may be modified to fit the linear or working range of the instrument. ]
Lanthanum chloride solution:
267 mg/mL of lanthanum chloride heptahydrate in 0.125 N hydrochloric acid
Calcium standard stock solution:
400 µg/mL of calcium
Dissolve 1.001 g of calcium carbonate, previously dried at 300 for 3 h and cooled in a desiccator for 2 h, and dissolve in 25 mL of 1 N hydrochloric acid. Boil to expel carbon dioxide, and dilute with water to 1000 mL.
for 3 h and cooled in a desiccator for 2 h, and dissolve in 25 mL of 1 N hydrochloric acid. Boil to expel carbon dioxide, and dilute with water to 1000 mL.
Standard stock solution:
100 µg/mL of calcium from Calcium standard solution diluted with 0.125 N hydrochloric acid
Standard solutions:
Into separate 100-mL volumetric flasks pipet 1.0, 1.5, 2.0, 2.5, and 3.0 mL of the Standard stock solution. To each flask add 1.0 mL of Lanthanum chloride solution, and dilute with water to volume to obtain Standard solutions having concentrations of 1.0, 1.5, 2.0, 2.5, and 3.0 µg/mL of calcium.
Sample stock solution:
Weigh and finely powder NLT 20 Tablets. Mix a portion of the powder equivalent to a nominal amount of 500 mg of calcium with 25 mL of concentrated hydrochloric acid, and heat for 30 min on a steam bath. Cool, dilute with water to 1000 mL, and filter.
Sample solution:
Quantitatively dilute a volume of the Sample stock solution with 0.125 N hydrochloric acid to obtain a nominal concentration of 100 µg/mL of calcium. Transfer 2.0 mL of this solution to a 100-mL volumetric flask, add 1.0 mL of Lanthanum chloride solution, and dilute with water to volume.
Spectrometric conditions
Mode:
Atomic absorption spectrophotometry
Lamp:
Calcium hollow-cathode
Flame:
Nitrous oxide–acetylene
Analytical wavelength:
Calcium emission line, 422.7 nm
Blank:
0.125 N hydrochloric acid containing 1 mL of Lanthanum chloride solution/100 mL
Analysis
Samples:
Standard solutions and Sample solution
Determine the absorbances of the solutions against the Blank. Plot the absorbances of the Standard solutions versus concentration, in µg/mL, of calcium, and draw the straight line best fitting the five plotted points. From the graph, determine the concentration, in µg/mL, of calcium in the Sample solution.
Calculate the percentage of the labeled amount of calcium (Ca) in the portion of Tablets taken:
Result = (C/CU) × 100
| C | = | = measured concentration of calcium in the Sample solution (µg/mL) |
| CU | = | = nominal concentration of calcium in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–125.0% of the labeled amount of Calcium (Ca)
• Copper, Method 1
Copper standard solution:
Dissolve 1.00 g of copper foil in a minimum volume of a 50% (v/v) solution of nitric acid solution, and dilute with a 1% (v/v) solution of nitric acid to 1000 mL. This solution contains 1000 µg/mL of copper.
Standard stock solution:
100 µg/mL of copper from Copper standard solution diluted with 0.125 N hydrochloric acid
Standard solutions:
To separate 200-mL volumetric flasks transfer 1.0, 2.0, 4.0, 6.0, and 8.0 mL of the Standard stock solution. Dilute with water to volume to obtain concentrations of 0.5, 1.0, 2.0, 3.0, and 4.0 µg/mL of copper.
Sample solution:
Weigh and finely powder NLT 20 Tablets. Transfer the equivalent of 5 mg of copper from powdered Tablets to a porcelain crucible. Heat for 6–12 h in a muffle furnace maintained at 550, and cool. Add 15 mL of hydrochloric acid, and boil gently on a hot plate or a steam bath for 30 min, intermittently rinsing the inner surface of the crucible with 6 N hydrochloric acid. Cool, and quantitatively transfer the contents of the crucible to a 100-mL volumetric flask, rinsing the crucible with portions of 6 N hydrochloric acid. Dilute the contents of the flask with water to volume, and filter, discarding the first 5 mL of the filtrate. Dilute the filtrate quantitatively with 0.125 N hydrochloric acid to obtain a concentration of 2 µg/mL of copper.
, and cool. Add 15 mL of hydrochloric acid, and boil gently on a hot plate or a steam bath for 30 min, intermittently rinsing the inner surface of the crucible with 6 N hydrochloric acid. Cool, and quantitatively transfer the contents of the crucible to a 100-mL volumetric flask, rinsing the crucible with portions of 6 N hydrochloric acid. Dilute the contents of the flask with water to volume, and filter, discarding the first 5 mL of the filtrate. Dilute the filtrate quantitatively with 0.125 N hydrochloric acid to obtain a concentration of 2 µg/mL of copper.
Spectrometric conditions
Mode:
Atomic absorption spectrophotometry
Lamp:
Copper hollow-cathode
Flame:
Air–acetylene
Analytical wavelength:
Copper emission line, 324.7 nm
Blank:
0.125 N hydrochloric acid
Analysis
Samples:
Standard solutions and Sample solution
Determine the absorbances of the solutions against the Blank. Plot the absorbances of the Standard solutions versus concentration, in µg/mL, of copper, and draw the straight line best fitting the five plotted points. From the graph, determine the concentration, C, in µg/mL, of copper in the Sample solution.
Calculate the percentage of the labeled amount of Copper (Cu) in the portion of Tablets taken:
Result = (C/CU) × 100
| C | = | = measured concentration of copper in the Sample solution (µg/mL) |
| CU | = | = nominal concentration of copper in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–125.0% of the labeled amount of copper (Cu)
• Magnesium, Method 1
Lanthanum chloride solution:
267 mg/mL of lanthanum chloride heptahydrate in 0.125 N hydrochloric acid
Magnesium standard stock solution:
Transfer 1.00 g of magnesium to a 1000-mL volumetric flask, dissolve in 50 mL of 6 N hydrochloric acid, dilute with water to volume, and mix to obtain a solution having a known concentration of 1000 µg/mL.
Standard stock solution:
20 µg/mL of magnesium from Magnesium standard stock solution diluted with 0.125 N hydrochloric acid
Standard solutions:
To separate 100-mL volumetric flasks transfer 1.0, 1.5, 2.0, 2.5, and 3.0 mL of Standard stock solution. To each flask add 1.0 mL of Lanthanum chloride solution, and dilute with 0.125 N hydrochloric acid to volume to obtain concentrations of 0.2, 0.3, 0.4, 0.5, and 0.6 µg/mL of magnesium.
Sample solution:
Finely powder NLT 20 Tablets. Transfer the equivalent of 200 mg of magnesium to a porcelain crucible. Heat for 6–12 h in a muffle furnace maintained at 550, and cool. Add 15 mL of hydrochloric acid, and boil gently on a hot plate or a steam bath for 30 min, intermittently rinsing the inner surface of the crucible with 6 N hydrochloric acid. Cool, and quantitatively transfer the contents of the crucible to a 100-mL volumetric flask, rinsing the crucible with portions of 6 N hydrochloric acid. Dilute the contents of the flask with water to volume, and filter, discarding the first 5 mL of the filtrate. Dilute the filtrate quantitatively with 0.125 N hydrochloric acid to obtain a concentration of 0.4 µg/mL of magnesium, adding 1 mL of Lanthanum chloride solution/100 mL of the final volume.
, and cool. Add 15 mL of hydrochloric acid, and boil gently on a hot plate or a steam bath for 30 min, intermittently rinsing the inner surface of the crucible with 6 N hydrochloric acid. Cool, and quantitatively transfer the contents of the crucible to a 100-mL volumetric flask, rinsing the crucible with portions of 6 N hydrochloric acid. Dilute the contents of the flask with water to volume, and filter, discarding the first 5 mL of the filtrate. Dilute the filtrate quantitatively with 0.125 N hydrochloric acid to obtain a concentration of 0.4 µg/mL of magnesium, adding 1 mL of Lanthanum chloride solution/100 mL of the final volume.
Spectrometric conditions
Mode:
Atomic absorption spectrophotometry
Lamp:
Magnesium hollow-cathode
Flame:
Air–acetylene
Analytical wavelength:
Magnesium emission line, 285.2 nm
Blank:
0.125 N hydrochloric acid containing 1 mL of Lanthanum chloride solution/100 mL
Analysis
Samples:
Standard solutions and Sample solution
Determine the absorbances of the solutions against the Blank. Plot the absorbances of the Standard solutions versus concentration, in µg/mL, of magnesium, and draw the straight line best fitting the five plotted points. From the graph, determine the concentration, C, in µg/mL, of magnesium in the Sample solution.
Calculate the percentage of the labeled amount of magnesium (Mg) in the portion of Tablets taken:
Result = (C/CU) × 100
| C | = | = measured concentration of magnesium in the Sample solution (µg/mL) |
| CU | = | = nominal concentration of magnesium in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–125.0% of the labeled amount of magnesium (Mg)
• Manganese, Method 1
Manganese standard stock solution:
Transfer 1.00 g of manganese, weighed, to a 1000-mL volumetric flask. Dissolve in 20 mL of nitric acid, dilute with 6 N hydrochloric acid to volume, and mix to obtain a solution with a concentration of 1000 µg/mL of manganese.
Standard stock solution:
50 µg/mL of manganese from Manganese standard stock solution diluted with 0.125 N hydrochloric acid
Standard solutions:
To separate 100-mL volumetric flasks transfer 1.0, 1.5, 2.0, 3.0, and 4.0 mL of the Standard stock solution. Dilute the contents of each flask with 0.125 N hydrochloric acid to volume to obtain solutions with concentrations of 0.5, 0.75, 1.0, 1.5, and 2.0 µg/mL of manganese.
Sample solution:
Finely powder NLT 20 Tablets. Transfer the equivalent of 9 mg of manganese from powdered Tablets to a porcelain crucible. Heat for 6–12 h in a muffle furnace maintained at 550, and cool. Add 15 mL of hydrochloric acid, and boil gently on a hot plate or a steam bath for 30 min, intermittently rinsing the inner surface of the crucible with 6 N hydrochloric acid. Cool, and quantitatively transfer the contents of the crucible to a 100-mL volumetric flask, rinsing the crucible with portions of 6 N hydrochloric acid. Dilute the contents of the flask with water to volume, and filter, discarding the first 5 mL of the filtrate. Dilute the filtrate quantitatively with 0.125 N hydrochloric acid to obtain a concentration of 1 µg/mL of manganese.
, and cool. Add 15 mL of hydrochloric acid, and boil gently on a hot plate or a steam bath for 30 min, intermittently rinsing the inner surface of the crucible with 6 N hydrochloric acid. Cool, and quantitatively transfer the contents of the crucible to a 100-mL volumetric flask, rinsing the crucible with portions of 6 N hydrochloric acid. Dilute the contents of the flask with water to volume, and filter, discarding the first 5 mL of the filtrate. Dilute the filtrate quantitatively with 0.125 N hydrochloric acid to obtain a concentration of 1 µg/mL of manganese.
Spectrometric conditions
Mode:
Atomic absorption spectrophotometry
Lamp:
Manganese hollow-cathode
Flame:
Air–acetylene
Analytical wavelength:
Manganese emission line, 279.5 nm
Blank:
0.125 N hydrochloric acid
Analysis
Samples:
Standard solutions and Sample solution
Determine the absorbances of the solutions against the Blank. Plot the absorbances of the Standard solutions versus the concentration, in µg/mL, of manganese, and draw the straight line best fitting the five plotted points. From the graph so obtained, determine the concentration, C, in mg/mL, of manganese in the Sample solution.
Calculate the percentage of the labeled amount of manganese (Mn) in the portion of Tablets taken:
Result = (C/CU) × 100
| C | = | = measured concentration of manganese in the Sample solution (µg/mL) |
| CU | = | = nominal concentration of manganese in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–125.0% of the labeled amount of manganese
• Zinc, Method 1
Zinc standard stock solution:
1000 µg/mL of zinc from zinc oxide dissolved in 5 M hydrochloric acid (3.89 mg/mL), and diluted with water to final volume. [Note—Dissolve in 5 M hydrochloric acid by warming, if necessary, cool, and then dilute to final volume. ]
Standard stock solution:
50 µg/mL of zinc from Zinc standard stock solution diluted with 0.125 N hydrochloric acid
Standard solutions:
Transfer 1.0, 2.0, 3.0, 4.0, and 5.0 mL of Standard stock solution to separate 100-mL volumentric flasks. Dilute the contents of each flask with 0.125 N hydrochloric acid to volume to obtain concentrations of 0.5, 1.0, 1.5, 2.0, and 2.5 µg/mL of zinc.
Sample solution:
Weigh and finely powder NLT 20 Tablets. Transfer the equivalent of 40 mg of zinc from powdered Tablets to a porcelain crucible. Heat for 6–12 h in a muffle furnace maintained at 550, and cool. Add 15 mL of hydrochloric acid, and boil gently on a hot plate or a steam bath for 30 min, intermittently rinsing the inner surface of the crucible with 6 N hydrochloric acid. Cool, and quantitatively transfer the contents of the crucible to a 100-mL volumetric flask, rinsing the crucible with portions of 6 N hydrochloric acid. Dilute the contents of the flask with water to volume, and filter, discarding the first 5 mL of the filtrate. Dilute the filtrate quantitatively with 0.125 N hydrochloric acid to obtain a concentration of 2 µg/mL of zinc.
, and cool. Add 15 mL of hydrochloric acid, and boil gently on a hot plate or a steam bath for 30 min, intermittently rinsing the inner surface of the crucible with 6 N hydrochloric acid. Cool, and quantitatively transfer the contents of the crucible to a 100-mL volumetric flask, rinsing the crucible with portions of 6 N hydrochloric acid. Dilute the contents of the flask with water to volume, and filter, discarding the first 5 mL of the filtrate. Dilute the filtrate quantitatively with 0.125 N hydrochloric acid to obtain a concentration of 2 µg/mL of zinc.
Spectrometric conditions
Mode:
Atomic absorption spectrophotometry
Lamp:
Zinc hollow-cathode
Flame:
Air–acetylene
Analytical wavelength:
Zinc emission line, 213.8 nm
Blank:
0.125 N hydrochloric acid
Analysis
Samples:
Standard solutions and Sample solution
Determine the absorbances of the solutions against the Blank. Plot the absorbances of the Standard solutions versus concentration, in µg/mL, of zinc, and draw the straight line best fitting the five plotted points. From the graph, determine the concentration, C, in µg/mL, of zinc in the Sample solution.
Calculate the percentage of the labeled amount of zinc (Zn) in the portion of Tablets taken:
Result = (C/CU) × 100
| C | = | = measured concentration of zinc in the Sample solution (µg/mL) |
| CU | = | = nominal concentration of zinc in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–125.0% of the labeled amount of zinc (Zn)
• Calcium, Copper, Magnesium, Manganese, and Zinc, Method 2
Stock aqua regia solution:
Prepare a mixture of hydrochloric acid and nitric acid (3:1) by adding the nitric acid to the hydrochloric acid. [Note—Periodically vent the solution in an appropriate fume hood. ]
Diluent:
Prepare a mixture of Stock aqua regia solution and water (1:9) by adding one volume of Stock aqua regia solution to two volumes of water. Dilute with additional water to volume, and mix well.
System suitability solution:
Prepare a mixture of 1000 mg/L of yttrium in 5% (v/v) nitric acid solution and 1000 mg/L of scandium in 5% (v/v) nitric acid solution with Diluent (1:1:198), and mix.
Standard stock solution (Ca, Cu, Mg, Mn, and Zn):
[Note—It is only necessary to include the minerals of interest in the solution. ] Using commercially available element standard (single- or multi-element) solutions in 5% (v/v) nitric acid solution, pipet the appropriate amount of element standard solution into a volumetric flask, and dilute with 5% (v/v) nitric acid solution to obtain a solution having final concentrations of about 1000 mg/L of calcium, 100 mg/L of copper, 500 mg/L of magnesium, 100 mg/L of manganese, and 250 mg/L of zinc.
Standard solutions:
Prepare a mixture of Standard stock solution in Diluent to prepare a six-point calibration curve to bracket the concentration range of each mineral of interest.
Sample solution:
Weigh and finely powder NLT 20 Tablets. Transfer a portion equal to the average Tablet weight to a 250-mL volumetric flask. Slowly add 25 mL of Stock aqua regia solution in 5-mL increments, followed by mixing. [Note—If the sample contains a carbonate, bubbling will occur. Wait until bubbling ends to proceed. ] Bring the solution to a boil on a hot plate. Continue to heat gently until fumes cease (about 1 h). Remove from heat, cool, and dilute with water to volume. Filter about 30 mL into a centrifuge tube using a 5-µm pore size nylon syringe filter. If necessary, make any further dilutions using the Diluent.
Spectrometric conditions
(See Spectrochemistry 
730
.)
730.)
Mode:
Inductively coupled plasma spectrometry, using a spectrometer set to measure the emission of each mineral of interest at about the corresponding wavelength.
[Note—The operating conditions may be developed and optimized based on the manufacturer's recommendation. The wavelengths selected should be demonstrated experimentally to provide sufficient specificity, sensitivity, linearity, accuracy, and precision. ]
System suitability
[Note—Analyze the System suitability solution and obtain the response as directed for Analysis. ]
Suitability requirements
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solutions and Sample solution
Determine the emission of each mineral of interest in the Standard solutions and Sample solution with an inductively coupled plasma system using the Diluent as the blank. Plot the emission of the Standard solutions versus concentration, in mg/L, of the minerals of interest, and draw the straight line best fitting the plotted points. From the graph, determine the concentration, C, in mg/L, for each mineral of interest in the Sample solution. Calculate the percentage of the labeled amount for each mineral:
Result = C × (V/W) × F × (WT/L) × 100
| C | = | = measured concentration of the relevant element in the Sample solution (mg/L) |
| V | = | = volume of the Sample solution (L) |
| W | = | = sample weight (mg) |
| F | = | = dilution factor of the Sample solution |
| WT | = | = average Tablet weight (mg) |
| L | = | = labeled amount of the relevant element (mg/Tablet) |
Acceptance criteria:
NLT 90.0%–125.0% of the labeled amount of calcium (Ca), copper (Cu), magnesium (Mg), manganese (Mn), and zinc (Zn).
PERFORMANCE TESTS
• Disintegration and Dissolution of Dietary Supplements 2040:
Meet the requirements for Dissolution with respect to calcium
2040:
Meet the requirements for Dissolution with respect to calcium
Medium:
0.1 N hydrochloric acid; 900 mL
Apparatus 2:
75 rpm
Time:
30 min
Analysis:
Determine the amount of calcium (Ca) dissolved, using the procedure in the assay for Calcium, making any necessary volumetric adjustments.
Tolerances:
NLT 75% of the labeled amount of Ca is dissolved.
• Weight Variation of Dietary Supplements 2091:
Meet the requirements
2091:
Meet the requirements
SPECIFIC TESTS
• Microbial Enumeration Tests—Nutritional and Dietary Supplements 2021:
The total aerobic microbial count does not exceed 3000 cfu/g, and the total combined molds and yeasts count does not exceed 300 cfu/g. Tablets also meet the requirements of the tests for absence of Salmonella species, Escherichia coli, and Staphylococcus aureus.
2021:
The total aerobic microbial count does not exceed 3000 cfu/g, and the total combined molds and yeasts count does not exceed 300 cfu/g. Tablets also meet the requirements of the tests for absence of Salmonella species, Escherichia coli, and Staphylococcus aureus.
• Absence of Specified Microorganisms—Nutritional and Dietary Supplements 2022:
Meet the requirements of the tests for absence of Salmonella species, Escherichia coli, and Staphylococcus aureus.
2022:
Meet the requirements of the tests for absence of Salmonella species, Escherichia coli, and Staphylococcus aureus.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
• Labeling:
The label states that the product is Calcium and Vitamin D with Minerals Tablets. The label also states the quantities of each mineral and vitamin D/dosage unit, the salt form of the mineral used as the source of each element present, and the chemical form of vitamin D present in the dosage unit.
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova
Scientific Liaison 1-301-816-8328 |
(DS2010) Monographs - Dietary Supplements |
| 2021 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 2022 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1221
Pharmacopeial Forum: Volume No. 34(6) Page 1491