Racemic Calcium Pantothenate
C18H32CaN2O10 476.53 -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.
[NoteThe physiological activity of Racemic Calcium Pantothenate is approximately one-half that of Calcium Pantothenate. ]
IDENTIFICATION
• B. Identification TestsGeneral, 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
Blank:
150 mL of water containing 2 mL of 3 N hydrochloric acid
Titrimetric system
(See Titrimetry 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
Acceptance criteria:
8.2%8.6% on the dried basis
IMPURITIES
SPECIFIC TESTS
• 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.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• Labeling:
Label preparations containing it in terms of the equivalent amount of dextrorotatory calcium pantothenate.
Auxiliary Information
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USP35NF30 Page 2462
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