Racemic Calcium Pantothenate
C18H32CaN2O10476.53
-Alanine, N-(2,4-dihydroxy-3,3-dimethyl-1-oxobutyl)-, calcium salt (2:1), (±)-;
Calcium dl-pantothenate (1:2)
[6381-63-1].
C18H32CaN2O10476.53
-Alanine, N-(2,4-dihydroxy-3,3-dimethyl-1-oxobutyl)-, calcium salt (2:1), (±)-; Calcium dl-pantothenate (1:2)
[6381-63-1].DEFINITION
Racemic Calcium Pantothenate is a mixture of the calcium salts of the dextrorotatory and levorotatory isomers 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.
[Note—The physiological activity of Racemic Calcium Pantothenate is approximately one-half that of Calcium Pantothenate. ]
IDENTIFICATION
• B. Identification Tests—General, Calcium 
191
: A 50-mg/mL solution meets the requirements.
191: A 50-mg/mL solution meets the requirements.COMPOSITION
• Nitrogen Determination, Method I 461
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
Blank: 150 mL of water containing 2 mL of 3 N hydrochloric acid
Titrimetric system
(See Titrimetry 541.)
541.)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 the 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
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
SPECIFIC TESTS
• Optical Rotation, Specific Rotation 781S
781S Test solution: 50 mg/mL in water
Acceptance criteria: 0.05
to +0.05
0.05 to +0.05• 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 1.6 mL of 0.10 N hydrochloric acid, and 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.
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.
• Labeling: Label preparations containing it in terms of the equivalent amount 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 | Huy T. Dinh, M.S. Scientific Liaison 1-301-816-8594 | (DS2010) Monographs - Dietary Supplements |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2462
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30.