Calcium Acetate Tablets
»Calcium Acetate Tablets contain not less than 90.0percent and not more than 110.0percent 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 100mg of calcium acetate per mL.This solution responds to the tests forCalcium á191ñand forAcetate á191ñ.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 2: 50rpm.
Time: 30minutes.
Procedure— Determine the amount of C4H6CaO4dissolved,employing atomic absorption spectrophotometry at a wavelength of about 422.8nm,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 C4H6CaO4is dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Limit of aluminum—
pH6.0acetate buffer— Prepare as directed in the test forLimit of aluminumunderCalcium Acetate.
Procedure— Weigh and finely powder not fewer than 10Tablets.Weigh accurately a portion of the powder,equivalent to about 1.0g of calcium acetate.Add 50mLof water and 5mLofpH6.0acetate buffer.Proceed as directed forProcedurein the test forLimit of aluminumunderCalcium Acetate.The indicated result is obtained (it does not exceed 2µg of aluminum per g of calcium acetate).
Assay— Weigh and finely powder not fewer than 20Tablets.Dissolve an accurately weighed portion of the powder,equivalent to about 300mg of calcium acetate,in 150mLof water containing 2mLof 3Nhydrochloric acid.While stirring,add 30mLof 0.05Medetate disodium VSfrom a 50-mLburet,and add 15mLof 1Nsodium hydroxide and 300mg of hydroxy naphthol blue.Continue the titration with the 0.05Medetate disodium VSto a blue endpoint.Each mLof 0.05Medetate disodium is equivalent to 7.909mg of calcium acetate (C4H6CaO4).
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 318
Pharmacopeial Forum:Volume No.27(6)Page 3254
Phone Number:1-301-816-8379