Ferrous Gluconate Tablets
» Ferrous Gluconate Tablets contain not less than 93.0 percent and not more than 107.0 percent 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 1 g of ferrous gluconate, in 100 mL of water, and filter: the solution so obtained, diluted with water, where necessary, responds to the Identification tests under Ferrous Gluconate.
Medium: simulated gastric fluid TS; 900 mL.
Apparatus 2: 150 rpm.
Time: 80 minutes.
Procedure Determine the amount of C12H22FeO14·2H2O dissolved, employing atomic absorption spectrophotometry at a wavelength of about 248.3 nm 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 C12H22FeO14·2H2O is dissolved in 80 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay Weigh and finely powder not fewer than 20 Tablets. Accurately weigh a portion of the powder, equivalent to about 1.5 g of ferrous gluconate, and dissolve in a mixture of 75 mL of water and 15 mL of 2 N sulfuric acid contained in a 300-mL conical flask. Proceed as directed in the Assay under Ferrous Gluconate, beginning with Add 250 mg of zinc dust. Each mL of 0.1 N ceric sulfate is equivalent to 48.22 mg of ferrous gluconate (C12H22FeO14·2H2O).
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USP32NF27 Page 2365