Calcium Acetate Tablets
» Calcium Acetate Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of calcium acetate (C4H6CaO4).
Packaging and storage— Preserve in well-closed containers.
Identification— Dissolve a portion of powdered Tablets in water to obtain a solution containing about 100 mg of calcium acetate per mL. This solution responds to the tests for Calcium 191 and for Acetate 191.
Dissolution 711—
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 30 minutes.
Procedure— Determine the amount of C4H6CaO4 dissolved, employing atomic absorption spectrophotometry at a wavelength of about 422.8 nm, in 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 80% (Q) of the labeled amount of C4H6CaO4 is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Limit of aluminum—
pH 6.0 acetate buffer— Prepare as directed in the test for Limit of aluminum under Calcium Acetate.
Procedure— Weigh and finely powder not fewer than 10 Tablets. Weigh accurately a portion of the powder, equivalent to about 1.0 g of calcium acetate. Add 50 mL of water and 5 mL of pH 6.0 acetate buffer. Proceed as directed for Procedure in the test for Limit of aluminum under Calcium Acetate. The indicated result is obtained (it does not exceed 2 µg of aluminum per g of calcium acetate).
Assay— Weigh and finely powder not fewer than 20 Tablets. Dissolve an accurately weighed portion of the powder, equivalent to about 300 mg of calcium acetate, in 150 mL of water containing 2 mL of 3 N hydrochloric acid. While stirring, add 30 mL of 0.05 M edetate disodium VS from a 50-mL buret, and add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue. Continue the titration with the 0.05 M edetate disodium VS to a blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 7.909 mg of calcium acetate (C4H6CaO4).
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Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
1-301-816-8345		 (MDPS05) Monograph Development-Pulmonary and Steroids
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
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USP32–NF27 Page 1753
Pharmacopeial Forum: Volume No. 27(6) Page 3254