Racemic Calcium Pantothenate

-Alanine, N-(2,4-dihydroxy-3,3-dimethyl-1-oxobutyl)-, calcium salt (2:1), (±)-;    
Calcium dl-pantothenate (1:2)    [6381-63-1].
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. ]
•  B. Identification Tests—General, Calcium 191: A 50-mg/mL solution meets the requirements.
•  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
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 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
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
•  Heavy Metals 231
Test preparation: 1.0 g in 25 mL of water
Acceptance criteria: NMT 20 ppm
•  Optical Rotation, Specific Rotation 781S
Test solution: 50 mg/mL in water
Acceptance criteria: 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.
•  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
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
(DS2010) Monographs - Dietary Supplements
Reference StandardsRS Technical Services
USP35–NF30 Page 2462
Chromatographic Column— 
Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30.