1/8/2020 USP Monographs: Calcium Pantothenate

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Calcium Pantothenate

C18H32CaN2O10 476.53

-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.

USP Reference standards 11 — USP Calcium Pantothenate RS.

Identification—

A: Infrared Absorption 197K .

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.

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1/8/2020 USP Monographs: Calcium Pantothenate

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 I 467 : meets the requirements.

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.

Residual solvents 467 : meets the requirements.

(Official January 1, 2007)

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

Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 358
Pharmacopeial Forum : Volume No. 27(6) Page 3260
Phone Number : 1-301-816-8389

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