Racemic Calcium Pantothenate, chemical structure, molecular formula, Reference Standards

Racemic Calcium Pantothenate

C18H32CaN2O10 476.53

b-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 5.7percent and not more than 6.0percent of nitrogen (N),and not less than 8.2percent and not more than 8.6percent 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.

USP Reference standards á11ñ— USP Calcium Pantothenate RS.

Specific rotation á781Sñ: between -0.05

and +0.05

Test solution: 50mg per mL,in water.

Alkalinity— Dissolve 1.0g in 15mLof carbon dioxide-free water in a small flask.As soon as solution is complete,add 1.6mLof 0.10Nhydrochloric acid,then add 0.05mLof phenolphthalein TS,and mix:no pink color is produced within 5seconds.

Organic volatile impurities,Method Iá467ñ: meets the requirements.

Other requirements— It responds to the Identificationtests and meets the requirements of the tests for Loss on drying,Heavy metals,Nitrogen content,and Calcium contentunder Calcium Pantothenate.

Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist

Expert Committee:(DSN)Dietary Supplements:Non-Botanicals

USP28–NF23Page 332

Phone Number:1-301-816-8389