Packaging and storage— Preserve in tight, light-resistant containers.

Labeling— Label the Oral Solution in terms of the content of ferrous sulfate (FeSO4·7H2O) and in terms of the content of elemental iron.

Identification— It responds to the tests for Ferrous Salts 191 and for Sulfate 191.

pH 791: between 1.4 and 5.3.

Residual solvents 467: meets the requirements.

Assay— Transfer to a 200-mL flask an accurately measured volume of Oral Solution, equivalent to about 625 mg of FeSO4·7H2O. Add 25 mL of 2 N sulfuric acid and 75 mL of freshly boiled and cooled water, then 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 27.80 mg of ferrous sulfate (FeSO4·7H2O).

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

USP29–NF24 Page 901

Phone Number : 1-301-816-8389