Ferrous Gluconate Oral Solution
» Ferrous Gluconate Oral Solution contains not less than 94.0 percent and not more than 106.0 percent of the labeled amount of ferrous gluconate (C12H22FeO14·2H2O).
Packaging and storage Preserve in tight, light-resistant containers.
Labeling Label the Oral Solution in terms of the content of ferrous gluconate (C12H22FeO14·2H2O) and in terms of the content of elemental iron.
Identification A volume of Oral Solution diluted, where necessary, with water meets the requirements of the Identification tests under Ferrous Gluconate.
pH 791: between 3.4 and 3.8.
Alcohol content 611: between 6.3% and 7.7% of C2H5OH.
Assay Transfer an accurately measured volume of Oral Solution, equivalent to about 1.2 g of ferrous gluconate, to a flask containing a cooled mixture of 80 mL of recently boiled water and 80 mL of 2 N sulfuric acid. Add orthophenanthroline TS, and immediately titrate with 0.1 N ceric sulfate VS. Perform a blank determination, and make any necessary correction. 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 2365Pharmacopeial Forum: Volume No. 28(2) Page 297