Calcium Pantothenate
-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 5.7 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.
Packaging and storage
Preserve in tight containers.
Identification
B:
A solution (1 in 20) responds to the tests for Calcium 191.
Specific rotation 781S:
between +25.0 and +27.5.
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 1.0 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.
Loss on drying 731
Dry it at 105 for 3 hours: it loses not more than 5.0% of its weight.
Heavy metals 231
Dissolve 1.0 g in 25 mL of water: the limit is 0.002%.
Ordinary impurities 466
Test solution:
water.
Standard solution:
water. Use USP Beta Alanine RS, in place of USP Calcium Pantothenate RS, as the Standard.
Eluant:
a mixture of alcohol and water (65:35).
Visualization:
4.
Limit:
1.0%.
Nitrogen content, Method I 461
Proceed as directed except to weigh accurately about 500 mg.
Content of calcium
Dissolve about 800 mg of Calcium Pantothenate, accurately weighed, 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 0.05 M edetate disodium VS until the solution is a distinct blue in color. Each mL of 0.05 M edetate disodium is equivalent to 2.004 mg of Ca.
Auxiliary Information
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Chromatographic Column
USP32NF27 Page 1768
Pharmacopeial Forum: Volume No. 32(1) Page 62
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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