Packaging and storage—
Preserve in tight containers.
Labeling—
Label the Tablets to indicate the content of dextrorotatory calcium pantothenate.
Identification—
A:
Digest a quantity of powdered Tablets, equivalent to about 150 mg of calcium pantothenate, with 15 mL of 1 N sodium hydroxide, and filter: the filtrate responds to
Identification test B under
Calcium Pantothenate.
B:
To 5 mL of the filtrate obtained in
Identification test A add 5 mL of 1 N hydrochloric acid and 2 drops of
ferric chloride TS: a strong yellow color is produced.
Dissolution, Procedure for a Pooled Sample 
711
—
Medium:
water; 900 mL.
Apparatus 2:
50 rpm.
Time:
45 minutes.
Procedure—
Determine the amount of C
18H
32CaN
2O
10 dissolved, employing the procedure set forth in the
Assay for calcium pantothenate,
Method 1, under
Water-Soluble Vitamins Tablets, except to omit the
Internal standard preparation, using filtered portions of the solution under test, suitably diluted with
Dissolution Medium if necessary, in comparison with a Standard solution having a known concentration of
USP Calcium Pantothenate RS in the same
Medium.
Tolerances—
Not less than 75% (Q) of the labeled amount of C18H32CaN2O10 is dissolved in 45 minutes.
Content of calcium—
Weigh and finely powder not fewer than 20 Tablets. Accurately weigh a portion of the powder, equivalent to about 500 mg of calcium pantothenate, transfer to a suitable crucible, and ignite, gently at first, until free from carbon. Cool the crucible, add 10 mL of water, and dissolve the residue by adding sufficient 3 N hydrochloric acid, dropwise, to achieve complete solution. Transfer the solution to a suitable container, dilute with water to 150 mL, 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 deep blue in color. Each mL of 0.05 M edetate disodium is equivalent to 2.004 mg of Ca. The content of Ca found is not less than 7.9% and not more than 9.7% of the weight of C
18H
32CaN
2O
10 in the Tablets, as determined by the
Assay.
Assay—
Weigh and finely powder not fewer than 20 Tablets. Weigh accurately a portion of the powder, equivalent to about 25 mg of calcium pantothenate, and transfer, with the aid of about 50 mL of water, to a 1000-mL volumetric flask. Add 2 mL of 1 N acetic acid and 100 mL of sodium acetate solution (1 in 60), then dilute with water to volume, and mix. Make further accurate dilutions, with water, to a concentration between 0.01 µg and 0.04 µg of calcium pantothenate per mL. Using this solution as the
Assay Preparation, proceed as directed under
Calcium Pantothenate Assay 91.
Auxiliary Information—
Staff Liaison :
Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 359
Pharmacopeial Forum : Volume No. 30(1) Page 81
Phone Number : 1-301-816-8389
