Packaging and storage—
Preserve in tight containers.
Labeling—
The quantity of calcium lactate stated in the labeling is in terms of calcium lactate pentahydrate.
Identification—
A:
A filtered solution of Tablets, equivalent to calcium lactate solution (1 in 20), responds to the tests for
Calcium 
191
.
Dissolution, Procedure for a Pooled Sample 711—
Medium:
water; 500 mL.
Apparatus 1:
100 rpm.
Time:
45 minutes.
Procedure—
Determine the amount of C
6H
10CaO
6·5H
2O 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.
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.
Auxiliary Information—
Staff Liaison :
Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 357
Pharmacopeial Forum : Volume No. 30(1) Page 81
Phone Number : 1-301-816-8389
