Ferrous Sulfate Oral Solution
DEFINITION
Ferrous Sulfate Oral Solution contains NLT 94.0% and NMT 106.0% of the labeled amount of ferrous sulfate heptahydrate (FeSO4·7H2O).
IDENTIFICATION
• A. Identification Tests—General, Iron, Ferrous Salts 
191
and Sulfate 191:
Meets the requirements
191 and Sulfate 191:
Meets the requirements
ASSAY
• Procedure
Sample:
A volume of Oral Solution equivalent to 625 mg of FeSO4·7H2O accurately measured
Blank:
Proceed as in the Analysis without the Sample.
Titrimetric system
(See Titrimetry 541.)
541.)
Mode:
Direct titration
Titrant:
0.1 N ceric sulfate VS
Indicator:
Orthophenanthroline TS
Endpoint detection:
Visual
Analysis:
Add 25 mL of 2 N sulfuric acid and 75 mL of freshly boiled and cooled water to the Sample, and shake well. Then add orthophenanthroline TS, and immediately titrate with Titrant until the color changes. Perform a blank determination.
Calculate the percentage of the labeled amount of ferrous sulfate heptahydrate (FeSO4·7H2O) in the Sample taken:
Result = {[(VS 
VB) × N × F]/W} × 100
VB) × N × F]/W} × 100| VS | = | = Titrant volume consumed by the Sample (mL) |
| VB | = | = Titrant volume consumed by the Blank (mL) |
| N | = | = actual normality of the Titrant (mEq/mL) |
| F | = | = equivalency factor, 278.0 mg/mEq |
| W | = | = nominal amount of ferrous sulfate heptahydrate in the Sample taken (mg) |
Acceptance criteria:
94.0%–106.0% of the labeled amount of ferrous sulfate heptahydrate (FeSO4·7H2O)
SPECIFIC TESTS
• pH 791:
1.4–5.3
791:
1.4–5.3
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
• Labeling:
Label the Oral Solution in terms of the content of ferrous sulfate heptahydrate (FeSO4·7H2O) and in terms of the content of elemental iron.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova
Scientific Liaison 1-301-816-8328 |
(DS2010) Monographs - Dietary Supplements |
USP35–NF30 Page 3180