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
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.
Acceptance criteria: Meet the requirements
•  B. Ultraviolet Absorption 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
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
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
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in tight containers.
•  USP Reference Standards 11
USP Niacinamide RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/QuestionContactExpert Committee
MonographNatalia Davydova
Scientific Liaison
1-301-816-8328
(DS2010) Monographs - Dietary Supplements
711Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
1-301-816-8106
(GCDF2010) General Chapters - Dosage Forms
Reference StandardsRS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 4044
Pharmacopeial Forum: Volume No. 30(1) Page 139