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 á191ñand for Sulfate á191ñ.

pHá791ñ: between 1.4and 5.3.

Assay— Transfer to a 200-mLflask an accurately measured volume of Oral Solution,equivalent to about 625mg of FeSO4·7H2O.Add 25mLof 2Nsulfuric acid and 75mLof freshly boiled and cooled water,then add orthophenanthroline TS,and immediately titrate with 0.1Nceric sulfate VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nceric sulfate is equivalent to 27.80mg of ferrous sulfate (FeSO4·7H2O).

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

USP28–NF23Page 821

Phone Number:1-301-816-8389