Fumaric Acid
C4H4O4 116.07
2-Butenedioic acid, E-;
Fumaric acid
[110-17-8].
(fue mar' ik as' id).
C4H4O4 116.07
2-Butenedioic acid, E-;
Fumaric acid
[110-17-8].DEFINITION
Fumaric Acid contains NLT 99.5% and NMT 100.5% of C4H4O4, calculated on the anhydrous basis.
IDENTIFICATION
ASSAY
• Procedure
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.
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
IMPURITIES
Organic Impurities
• 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
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4.6-mm × 22-cm; packing L17
Flow rate:
0.3 mL/min
Injection size:
5 µL
System suitability
Sample:
System suitability solution
[Note—The relative retention times for maleic acid and fumaric acid are about 0.5 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 2.5 of the maleic acid and fumaric acid peaks
Relative standard deviation:
NMT 2.0% of the maleic acid peak
Analysis
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
| rU | = | = peak response of maleic acid from the Sample solution |
| rS | = | = peak response of maleic acid from the Standard solution |
| CS | = | = concentration of USP Maleic Acid RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of the Sample solution (mg/mL) |
Acceptance criteria:
NMT 0.1%
SPECIFIC TESTS
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
') + '&img=../../images/v35300/cas-110-17-8.gif',600,500);)
') + '&img=../../images/v35300/cas-110-16-7.gif',600,500);)
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1805
Pharmacopeial Forum: Volume No. 35(3) Page 598