Niacinamide
C6H6N2O 122.12
3-Pyridinecarboxamide;
Nicotinamide
[98-92-0].
(nye'' a sin' a mide).
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C6H6N2O 122.12
3-Pyridinecarboxamide;
Nicotinamide
[98-92-0].DEFINITION
Niacinamide contains NLT 98.5% and NMT 101.5% of niacinamide (C6H6N2O), calculated on the dried basis.
IDENTIFICATION
• B. Ultraviolet Absorption 
197U
197U
Sample solution:
20 µg/mL in water
Acceptance criteria:
It meets the requirements in the chapter, and the A245/A262 ratio is 0.63–0.67.
ASSAY
• Procedure
Mobile phase:
Methanol and 0.005 M sodium 1-heptanesulfonate (30:70)
Standard solution:
Transfer 50 mg of USP Niacinamide RS to a 100-mL volumetric flask. Add 3 mL of water to dissolve, and dilute with Mobile phase to volume. Dilute with Mobile phase to 0.04 mg/mL.
Niacin standard solution
Prepare as directed in the Standard solution, using USP Niacin RS instead of USP Niacinamide RS.
Sample solution:
Prepare as directed in the Standard solution, using Niacinamide instead of USP Niacinamide RS.
System suitability solution:
Mix equal volumes of the Standard solution and Niacin standard solution.
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
3.9-mm × 30-cm; packing L1
Flow rate:
2 mL/min
Injection size:
20 µL
System suitability
Samples:
Standard solution and System suitability solution
Suitability requirements
Resolution:
NLT 3.0 between niacin and niacinamide, System suitability solution
Relative standard deviation:
NMT 2.0%, Standard solution
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of niacinamide (C6H6N2O) in the portion of Niacinamide taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak area from the Sample solution |
| rS | = | = peak area from the Standard solution |
| CS | = | = concentration of USP Niacinamide RS in the Standard solution (mg/mL) |
| CU | = | = concentration of Niacinamide in the Sample solution (mg/mL) |
Acceptance criteria:
98.5%–101.5% on the dried basis
IMPURITIES
• Residue on Ignition 281:
NMT 0.1%
281:
NMT 0.1%
• Heavy Metals, Method II 231:
NMT 30 ppm
231:
NMT 30 ppm
• Readily Carbonizable Substances 271
271
Sample solution:
Dissolve 200 mg of Niacinamide in 5 mL of sulfuric acid.
Acceptance criteria:
The Sample solution has no more color than Matching Fluid A.
SPECIFIC TESTS
• Melting Range or Temperature 741:
128
–131
741:
128–131
• Loss on Drying 731:
Dry a sample over silica gel for 4 h: it loses NMT 0.5% of its weight.
731:
Dry a sample over silica gel for 4 h: it loses NMT 0.5% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Huy T. Dinh, M.S.
Scientific Liaison 1-301-816-8594 |
(DS2010) Monographs - Dietary Supplements |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4043
Pharmacopeial Forum: Volume No. 34(5) Page 1176