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2-Butenedioic acid, E-;
Fumaric acid [110-17-8].
Fumaric Acid contains NLT 99.5% and NMT 100.5% of C4H4O4, calculated on the anhydrous basis.
Sample solution: Dissolve 1 g of Fumaric Acid in 50 mL of methanol, and warm gently on a steam bath to effect solution. Cool, and add phenolphthalein TS.
Analysis: Titrate the Sample solution with 0.5 N sodium hydroxide VS to the first appearance of a pink color that persists for not less than 30 s. Perform a blank titration (see Titrimetry 541). Each mL of 0.5 N sodium hydroxide is equivalent to 29.02 mg of C4H4O4.
Acceptance criteria: 99.5%100.5% on the anhydrous basis
• Procedure: Limit of Maleic Acid
Mobile phase: 0.005 N sulfuric acid
Standard solution: 1 µg/mL of USP Maleic Acid RS in Mobile phase
Sample solution: 1 mg/mL of Fumaric Acid in Mobile phase
System suitability solution: 10 µg/mL of USP Fumaric Acid RS and 5 µg/mL of USP Maleic Acid RS in Mobile phase
Detector: UV 210 nm
Column: 4.6-mm × 22-cm; packing L17
Flow rate: 0.3 mL/min
Injection size: 5 µL
Sample: System suitability solution
[NoteThe relative retention times for maleic acid and fumaric acid are about 0.5 and 1.0, respectively. ]
Resolution: NLT 2.5 of the maleic acid and fumaric acid peaks
Relative standard deviation: NMT 2.0% of the maleic acid peak
Samples: Standard solution and Sample solution
Calculate the percentage of maleic acid in the total weight of Fumaric Acid taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: NMT 0.1%
• Packaging and Storage: Preserve in well-closed containers.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 1805Pharmacopeial Forum: Volume No. 35(3) Page 598