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.
Limit of aluminum—
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).
Auxiliary Information—
Staff Liaison :
Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 345
Pharmacopeial Forum : Volume No. 27(6) Page 3254
Phone Number : 1-301-816-8143
