Niacinamide Tablets
DEFINITION
Niacinamide Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of niacinamide (C6H6N2O).
IDENTIFICATION
• A. Infrared Absorption 
197K
197K
Sample:
Extract a quantity of powdered Tablets, equivalent to 500 mg of niacinamide, with two 10-mL portions of alcohol, evaporate the filtered alcohol extracts on a steam bath, and dry at 80
for 2 h.
for 2 h.
Acceptance criteria:
Meet the requirements
• B. Ultraviolet Absorption 197U
197U
Sample solution:
20 µg/mL of niacinamide in water from the Sample obtained in Identification test A
Acceptance criteria:
Meets the requirements in the chapter. The ratio A245/A262 is 0.63–0.67.
ASSAY
• Niacin or Niacinamide Assay, Chemical Method 441
441
Standard niacinamide preparation:
Prepare as directed in the chapter.
Assay preparation:
Transfer an equivalent of 25 mg of niacinamide, from NLT 10 finely powdered Tablets, to a suitable flask. Add 50 mL of water and heat, if necessary, until no more dissolves. Cool, dilute with water to 10 µg/mL, mix, and filter.
Analysis:
Proceed as directed in the chapter for Procedure.
Calculate the percentage of the labeled amount of niacinamide (C6H6N2O) in the portion of Tablets taken:
Result = (AU/AS) × (CS/CU) × 100
| AU | = | = absorbance of the Assay preparation |
| AS | = | = absorbance of the Standard niacinamide preparation |
| CS | = | = concentration of the Standard niacinamide preparation (µg/mL) |
| CU | = | = nominal concentration of niacinamide in the Assay preparation (µg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution, Procedure for a Pooled Sample 711
711
Medium:
Water; 900 mL
Apparatus 2:
50 rpm
Time:
45 min
Standard solution:
Known concentration of USP Niacinamide RS in the Medium
Sample solution:
Filtered portion of the solution under test, suitably diluted with the Medium if necessary
Mobile phase:
A mixture of methanol, glacial acetic acid, and water (27:1:73) containing 140 mg of sodium 1-hexanesulfonate per 100 mL
Chromatographic system
Mode:
LC
Detector:
UV 280 nm
Column:
3.9-mm × 30-cm; packing L1
Flow rate:
1 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Relative standard deviation:
NMT 3.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of niacinamide (C6H6N2O) dissolved:
Result = (rU/rS) × (CS × D × V/L) × 100
| rU | = | = peak area of niacinamide from the Sample solution |
| rS | = | = peak area of niacinamide from the Standard solution |
| CS | = | = concentration of USP Niacinamide RS in the Standard solution (mg/mL) |
| D | = | = dilution factor for the Sample solution |
| V | = | = volume of Medium, 900 mL |
| L | = | = label claim (mg/Tablet) |
Tolerances:
NLT 75% (Q) of the labeled amount of niacinamide (C6H6N2O) is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• USP Reference Standards 11
11
USP Niacinamide RS 
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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 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4044
Pharmacopeial Forum: Volume No. 30(1) Page 139