Calcium Lactate Tablets
» Calcium Lactate Tablets contain not less than 94.0 percent and not more than 106.0 percent of the labeled amount of calcium lactate (C6H10CaO6·5H2O).
noteAn equivalent amount of Calcium Lactate with less water of hydration may be used in place of C6H10CaO6·5H2O in preparing Calcium Lactate Tablets.
Packaging and storage Preserve in tight containers.
Labeling The quantity of calcium lactate stated in the labeling is in terms of calcium lactate pentahydrate.
A: A filtered solution of Tablets, equivalent to calcium lactate solution (1 in 20), responds to the tests for Calcium 191.
B: A filtered solution of Tablets, equivalent to calcium lactate solution (1 in 20), responds to the tests for Lactate 191.
Dissolution, Procedure for a Pooled Sample 711
Medium: water; 500 mL.
Apparatus 1: 100 rpm.
Time: 45 minutes.
Procedure Determine the amount of C6H10CaO6·5H2O dissolved, employing the procedure set forth in the Assay, making any necessary modifications.
Tolerances Not less than 75% (Q) of the labeled amount of C6H10CaO6·5H2O is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay Weigh and finely powder not fewer than 20 Tablets. Accurately weigh a portion of the powder, equivalent to about 350 mg of C6H10CaO6·5H2O, transfer to a suitable container, and add 150 mL of water and 2 mL of 3 N hydrochloric acid. Stir, using a magnetic stirrer, for 3 to 5 minutes. While stirring, add about 30 mL of 0.05 M edetate disodium VS from a 50-mL buret. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to a blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 15.42 mg of C6H10CaO6·5H2O.
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USP32NF27 Page 1767Pharmacopeial Forum: Volume No. 31(6) Page 1609