Ferrous Gluconate Tablets
»Ferrous Gluconate Tablets contain not less than 93.0percent and not more than 107.0percent of the labeled amount of ferrous gluconate (C12H22FeO14·2H2O).
Packaging and storage— Preserve in tight containers.
Labeling— Label the Tablets in terms of the content of ferrous gluconate (C12H22FeO14·2H2O)and in terms of the content of elemental iron.
Identification— Dissolve a quantity of powdered Tablets,equivalent to about 1g of ferrous gluconate,in 100mLof water,and filter:the solution so obtained,diluted with water,where necessary,responds to the Identificationtests under Ferrous Gluconate.
Dissolution á711ñ—
Medium: simulated gastric fluid TS;900mL.
Apparatus 2: 150rpm.
Time: 80minutes.
Procedure— Determine the amount of C12H22FeO14·2H2Odissolved,employing atomic absorption spectrophotometry at a wavelength of about 248.3nm on filtered portions of the solution under test,suitably diluted with Dissolution Medium,in comparison with a Standard solution having a known concentration of iron in the same Medium.
Tolerances— Not less than 80%(Q)of the labeled amount of C12H22FeO14·2H2Ois dissolved in 80minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Weigh and finely powder not fewer than 20Tablets.Accurately weigh a portion of the powder,equivalent to about 1.5g of ferrous gluconate,and dissolve in a mixture of 75mLof water and 15mLof 2Nsulfuric acid contained in a 300-mLconical flask.Proceed as directed in the Assayunder Ferrous Gluconate,beginning with “Add 250mg of zinc dust.”Each mLof 0.1Nceric sulfate is equivalent to 48.22mg of ferrous gluconate (C12H22FeO14·2H2O).
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 821
Phone Number:1-301-816-8389