Calcium Pantothenate
(kal' see um pan" toe then' ate).
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C18H32CaN2O10476.53
-Alanine, N-(2,4-dihydroxy-3,3-dimethyl-1-oxobutyl)-, calcium salt (2:1), (R)-;    
Calcium d-pantothenate (1:2)    [137-08-6].
DEFINITION
Calcium Pantothenate is the calcium salt of the dextrorotatory isomer of pantothenic acid. It contains NLT 5.7% and NMT 6.0% of nitrogen (N), and NLT 8.2% and NMT 8.6% of calcium (Ca), both calculated on the dried basis.
IDENTIFICATION
•  B. Identification Tests—General, Calcium 191: A 50-mg/mL solution meets the requirements.
COMPOSITION
•  Nitrogen Determination, Method I 461
Sample: 500 mg
Analysis: Proceed as directed in the chapter.
Acceptance criteria: 5.7%–6.0% on the dried basis
•  Content of Calcium
Sample: 800 mg of Calcium Pantothenate
Blank: 150 mL of water containing 2 mL of 3 N hydrochloric acid
Titrimetric system 
Mode: Direct titration
Titrant: 0.05 M edetate disodium VS
Endpoint detection: Visual
Analysis: Dissolve the Sample in 150 mL of water containing 2 mL of 3 N hydrochloric acid. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and titrate with Titrant to a distinct blue endpoint. Perform the Blank determination.
Calculate the percentage of calcium (Ca) in the Sample taken:
Result = {[(VS 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== Sample weight (mg)
Acceptance criteria: 8.2%–8.6% on the dried basis
IMPURITIES
•  Heavy Metals 231
Test preparation: 1.0 g in 25 mL of water
Acceptance criteria: NMT 20 ppm
•  Ordinary Impurities 466
Standard solution: Use water as the solvent. Use USP Beta Alanine RS, in place of USP Calcium Pantothenate RS, as the Standard.
Test solution: Use water as the solvent.
Eluant: Alcohol and water (65:35)
Visualization: 4
Acceptance criteria: NMT 1.0%
SPECIFIC TESTS
•  Optical Rotation, Specific Rotation 781S
Sample solution: 50 mg/mL in water
Acceptance criteria: +25.0 to +27.5
•  Alkalinity
Sample: 1.0 g
Analysis: Dissolve the Sample in 15 mL of carbon dioxide-free water in a small flask. As soon as the solution is complete, add 1.0 mL of 0.10 N hydrochloric acid, then add 0.05 mL of phenolphthalein TS.
Acceptance criteria: No pink color is produced within 5 s.
•  Loss on Drying 731: Dry a sample at 105 for 3 h: it loses NMT 5.0% of its weight.
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in tight containers.
•  USP Reference Standards 11
USP Beta Alanine RS Click to View Structure
3-Aminopropionic acid.
USP Calcium Pantothenate RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/QuestionContactExpert Committee
MonographHuy T. Dinh, M.S.
Scientific Liaison
1-301-816-8594
(DS2010) Monographs - Dietary Supplements
Reference StandardsRS Technical Services
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rstech@usp.org
USP35–NF30 Page 2461
Pharmacopeial Forum: Volume No. 32(1) Page 62
Chromatographic Column— 
Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30.