Calcium Pantothenate Tablets
DEFINITION
Calcium Pantothenate Tablets contain NLT 95.0% and NMT 115.0% of the labeled amount of the dextrorotatory isomer of calcium pantothenate (C18H32CaN2O10).
IDENTIFICATION
• A. Identification Tests—General, Calcium 
191
191
Sample solution:
Digest a quantity of powdered Tablets, equivalent to 150 mg of calcium pantothenate, with 15 mL of 1 N sodium hydroxide, and filter.
Acceptance criteria:
Meet the requirements
• B.
Sample solution:
5 mL of the filtrate obtained in Identification test A
Analysis:
Add 5 mL of 1 N hydrochloric acid and 2 drops of ferric chloride TS to the Sample solution.
Acceptance criteria:
A strong yellow color is produced.
ASSAY
• Calcium Pantothenate Assay 91
91
Assay preparation:
Weigh and finely powder NLT 20 Tablets. Weigh a portion of the powder, equivalent to 25 mg of calcium pantothenate, and transfer, with the aid of about 50 mL of water, to a 1000-mL volumetric flask. Add 2 mL of 1 N acetic acid and 100 mL of sodium acetate solution (1 in 60), then dilute with water to volume. Make further accurate dilutions, with water, to a concentration between 0.01 and 0.04 µg/mL of calcium pantothenate.
Acceptance criteria:
95.0%–115.0%
OTHER COMPONENTS
• Content of Calcium
Sample:
A portion of the powder from NLT 20 finely powdered Tablets, equivalent to 500 mg of calcium pantothenate
Blank:
Proceed as directed in the Analysis, without the Sample.
Titrimetric system
(See Titrimetry 541.)
541.)
Mode:
Direct titration
Titrant:
0.05 M edetate disodium VS
Indicator:
Hydroxy naphthol blue, 300 mg
Endpoint detection:
Visual
Analysis:
Transfer the Sample to a a suitable crucible. Ignite, gently at first, until free from carbon. Cool the crucible. Add 10 mL of water, and dissolve the residue by adding sufficient 3 N hydrochloric acid, dropwise, to achieve complete solution. Transfer the solution to a suitable container, and dilute with water to 150 mL. Add 15 mL of 1 N sodium hydroxide, then add the Indicator. Titrate with Titrant to a distinct blue endpoint. Perform a Blank determination.
Calculate the percentage of calcium in the content of calcium pantothenate, as determined by the Assay, in the portion of Tablets taken:
Result = {[(VS 
VB) × M × F]/W} × 100
VB) × M × F]/W} × 100| VS | = | = Titrant volume consumed by the Sample (mL) |
| VB | = | = Titrant volume consumed by the Blank (mL) |
| M | = | = actual molarity of the Titrant (mM/mL) |
| F | = | = equivalency factor, 40.08 mg/mM |
| W | = | = weight of calcium pantothenate in the Sample taken, as determined by the Assay (mg) |
Acceptance criteria:
7.9%–9.7% of the weight of calcium pantothenate (C18H32CaN2O10) in the Tablets, as determined by the Assay
PERFORMANCE TESTS
• Dissolution, Procedure for a Pooled Sample 711
711
Medium:
Water; 900 mL
Apparatus 2:
50 rpm
Time:
45 min
Mobile phase:
Phosphoric acid and water (1:1000)
Standard solution:
A known concentration of USP Calcium Pantothenate RS in Medium
Sample solution:
A filtered portion of the solution under test, suitably diluted with Medium if necessary, having a concentration of C18H32CaN2O10 similar to that of the Standard solution
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
3.9-mm × 15-cm; packing L1
Flow rate:
1.5 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Relative standard deviation:
NMT 3.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of calcium pantothenate (C18H32CaN2O10) dissolved:
Result = (rU/rS) × (CS × D × V/L) × 100
| rU | = | = peak area of calcium pantothenate from the Sample solution |
| rS | = | = peak area of calcium pantothenate from the Standard solution |
| CS | = | = concentration of the Standard solution (mg/mL) |
| DS | = | = dilution factor for the Sample solution |
| V | = | = volume of Medium, 900 mL |
| L | = | = label claim (mg/Tablet) |
Tolerances:
NLT 75% (Q) of the labeled amount of calcium pantothenate (C18H32CaN2O10) is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• Labeling:
Label the Tablets to indicate the content of dextrorotatory calcium pantothenate.
• USP Reference Standards 11
11
USP Calcium Pantothenate RS 
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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 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2461
Pharmacopeial Forum: Volume No. 30(1) Page 81