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).
note—An 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.
Identification—
A:
A filtered solution of Tablets, equivalent to calcium lactate solution (1 in 20), responds to the tests for Calcium 
191
.
191.
B:
A filtered solution of Tablets, equivalent to calcium lactate solution (1 in 20), responds to the tests for Lactate 191.
191.
Dissolution, Procedure for a Pooled Sample 711—
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.
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Curtis Phinney
1-301-816-8540 |
(DSN05) Dietary Supplements - Non-Botanicals |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientist 1-301-816-8106 |
(BPC05) Biopharmaceutics05 |
USP32–NF27 Page 1767
Pharmacopeial Forum: Volume No. 31(6) Page 1609