Niacinamide

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₆H₆N₂O       122.12

3-Pyridinecarboxamide;

Nicotinamide CAS RN^®: 98-92-0; UNII: 25X5118RD4.

1 DEFINITION

Niacinamide contains NLT 98.5% and NMT 101.5% of niacinamide (C₆H₆N₂O), calculated on the dried basis.

2 IDENTIFICATION

Change to read:

A. ^▲SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K _{▲(CN 1-MAY-2020)}

Change to read:

B. ^▲SPECTROSCOPIC IDENTIFICATION TESTS (197), Ultraviolet-Visible Spectroscopy; 197U_{▲(CN 1-MAY-2020)}

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.

3 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

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 3.9-mm x 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 = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak area from the Sample solution

r_S = peak area from the Standard solution 

C_S = concentration of USP Niacinamide RS in the Standard solution (mg/mL)

C_U = concentration of Niacinamide in the Sample solution (mg/mL)

Acceptance criteria: 98.5%-101.5% on the dried basis

4 IMPURITIES

4.1 RESIDUE ON IGNITION (281)

NMT 0.1%

4.2 READILY CARBONIZABLE SUBSTANCES (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.

5 SPECIFIC TESTS

MELTING RANGE OR TEMPERATURE (741): 128°-131"

LOSS ON DRYING (731): Dry a sample over silica gel for 4 h: it loses NMT 0.5% of its weight.

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers.

USP REFERENCE STANDARDS (11)

USP Niacin RS

USP Niacinamide RS