Calcium Pantothenate
;)
b-Alanine,N-(2,4-dihydroxy-3,3-dimethyl-1-oxobutyl)-,calcium salt (2:1),(R)-.
Calcium D-pantothenate (1:2) [137-08-6].
»Calcium Pantothenate is the calcium salt of the dextrorotatory isomer 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.
Packaging and storage—
Preserve in tight containers.
Identification—
A:Infrared Absorption á197Kñ.
B:
Asolution (1in 20)responds to the tests for Calcium á191ñ.
Specific rotation á781Sñ:
between +25.0
and +27.5.
and +27.5.
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 1.0mLof 0.10Nhydrochloric acid,then add 0.05mLof phenolphthalein TS,and mix:no pink color is produced within 5seconds.
Loss on drying á731ñ—
Dry it at 105for 3hours:it loses not more than 5.0%of its weight.
for 3hours:it loses not more than 5.0%of its weight.
Heavy metals á231ñ—
Dissolve 1.0g in 25mLof water:the limit is 0.002%.
Ordinary impurities á466ñ—
Test solution:
water.
Standard solution:
water.Use 3-aminopropionic acid,in place of USP Calcium Pantothenate RS,as the standard.
Eluant:
a mixture of alcohol and water (65:35).
Visualization:
4.
Limit:
1.0%.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Nitrogen content Method Iá461ñ—
Proceed as directed except to weigh accurately about 500mg.
Content of calcium
—Dissolve about 800mg of Calcium Pantothenate,accurately weighed,in 150mLof water containing 2mLof 3Nhydrochloric acid.Add 15mLof 1Nsodium hydroxide and 300mg of hydroxy naphthol blue,and titrate with 0.05Medetate disodium VSuntil the solution is a distinct blue in color.Each mLof 0.05Medetate disodium is equivalent to 2.004mg of Ca.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 331
Pharmacopeial Forum:Volume No.27(6)Page 3260
Phone Number:1-301-816-8389