Calcium Gluconate Tablets
» Calcium Gluconate Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of calcium gluconate (C12H22CaO14).
Packaging and storage—
Preserve in well-closed containers.
USP Reference standards 
11
—
USP Potassium Gluconate RS.
11—
USP Potassium Gluconate RS.
Identification—
A warm, filtered solution of Tablets, equivalent to calcium gluconate solution (1 in 10), diluted with water, where necessary, responds to the Identification tests under Calcium Gluconate.
Dissolution 711—
711—
Medium:
water; 900 mL.
Apparatus 2:
50 rpm.
Time:
45 minutes.
Procedure—
Determine the amount of C12H22CaO14 dissolved, employing atomic absorption spectrophotometry at a wavelength of about 422.8 nm on filtered portions of the solution under test, suitably diluted with water, in comparison with a Standard solution having a known concentration of calcium in the same Medium.
Tolerances—
Not less than 75% (Q) of the labeled amount of C12H22CaO14 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. Transfer an accurately weighed portion of the powder, equivalent to about 500 mg of calcium gluconate, 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, and while stirring, preferably with a magnetic stirrer, add about 20 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 21.52 mg of calcium gluconate (C12H22CaO14).
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 |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientist 1-301-816-8106 |
(BPC05) Biopharmaceutics05 |
USP32–NF27 Page 1765
Pharmacopeial Forum: Volume No. 27(6) Page 3258