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.

USP Reference standards 11— USP Potassium Gluconate RS.

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.

Residual solvents 467: meets the requirements.

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).

Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals

USP29–NF24 Page 900

Phone Number : 1-301-816-8389