Ferrous Sulfate Oral Solution

» Ferrous Sulfate Oral Solution contains not less than 94.0 percent and not more than 106.0 percent of the labeled amount of ferrous sulfate (FeSO4·7H2O).

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

791

: between 1.4 and 5.3.

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).

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Topic/Question	Contact	Expert Committee
Monograph	Curtis Phinney 1-301-816-8540	(DSN05) Dietary Supplements - Non-Botanicals

USP32–NF27 Page 2365