Calcium Gluconate Tablets
»Calcium Gluconate Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of calcium gluconate (C12H22CaO14).
Packaging and storage— Preserve in well-closed containers.
Identification— Awarm,filtered solution of Tablets,equivalent to calcium gluconate solution (1in 10),diluted with water,where necessary,responds to the Identificationtests under Calcium Gluconate.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 2: 50rpm.
Time: 45minutes.
Procedure— Determine the amount of C12H22CaO14dissolved,employing atomic absorption spectrophotometry at a wavelength of about 422.8nm 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 C12H22CaO14is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 500mg of calcium gluconate,to a suitable crucible,and ignite,gently at first,until free from carbon.Cool the crucible,add 10mLof water,and dissolve the residue by adding sufficient 3Nhydrochloric acid,dropwise,to achieve complete solution.Transfer the solution to a suitable container,dilute with water to 150mL,and while stirring,preferably with a magnetic stirrer,add about 20mLof 0.05Medetate disodium VSfrom a 50-mLburet.Add 15mLof 1Nsodium hydroxide and 300mg of hydroxy naphthol blue,and continue the titration to a blue endpoint.Each mLof 0.05Medetate disodium is equivalent to 21.52mg of calcium gluconate (C12H22CaO14).
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 328
Pharmacopeial Forum:Volume No.27(6)Page 3258
Phone Number:1-301-816-8389