Calcium Pantothenate Tablets
» Calcium Pantothenate Tablets contain not less than 95.0 percent and not more than 115.0 percent of the labeled amount of the dextrorotatory isomer of calcium pantothenate (C18H32CaN2O10).
Packaging and storage Preserve in tight containers.
Labeling Label the Tablets to indicate the content of dextrorotatory calcium pantothenate.
USP Reference standards 11
USP Calcium Pantothenate RS.
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 C18H32CaN2O10 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.
Uniformity of dosage units 905: meet the requirements.
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 C18H32CaN2O10 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.
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USP32NF27 Page 1769Pharmacopeial Forum: Volume No. 30(1) Page 81