Ferrous Sulfate Oral Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Ferrous Sulfate Oral Solution contains NLT 94.0% and NMT 106.0% of the labeled amount of ferrous sulfate heptahydrate (FeSO4 · 7H2O).
2 IDENTIFICATION
A. Identification Tests—General, Iron, Ferrous Salts〈191〉andSulfate〈191〉: Meets the requirements
3 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〉.) 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
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)
4 SPECIFIC TESTS
pH 〈791〉: 1.4–5.3
5 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.
