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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].
» Racemic Calcium Pantothenate is a mixture of the calcium salts of the dextrorotatory and levorotatory isomers of pantothenic acid. It contains not less than 5.7 percent and not more than 6.0 percent of nitrogen (N), and not less than 8.2 percent and not more than 8.6 percent 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.
Packaging and storage— Preserve in tight containers.
Labeling— Label preparations containing it in terms of the equivalent amount of dextrorotatory calcium pantothenate.
Specific rotation 781S: between 0.05 and +0.05.
Test solution: 50 mg per mL, in water.
Alkalinity— Dissolve 1.0 g in 15 mL of carbon dioxide-free water in a small flask. As soon as solution is complete, add 1.6 mL of 0.10 N hydrochloric acid, then add 0.05 mL of phenolphthalein TS, and mix: no pink color is produced within 5 seconds.
Organic volatile impurities, Method I 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It responds to the Identification tests and meets the requirements of the tests for Loss on drying, Heavy metals, Nitrogen content, and Calcium content under Calcium Pantothenate.
Auxiliary Information— Staff Liaison : Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 359
Phone Number : 1-301-816-8389