Niacinamide Tablets

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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1 DEFINITION

Niacinamide Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of niacinamide (C₆H₆N₂O).

2 IDENTIFICATION

Change to read:

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

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

Change to read:

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

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.

3 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 = (A_U/A_S) × (C_S/C_U) × 100

A_U = absorbance of the Assay preparation

A_S = absorbance of the Standard niacinamide preparation

C_S = concentration of the Standard niacinamide preparation (µg/mL)

C_U = nominal concentration of niacinamide in the Assay preparation (µg/mL)

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

4.1 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

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 3.9-mm x 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 = (r_U/r_S) × (C_S × D × V/L) x 100 

r_U = peak area of niacinamide from the Sample solution

r_S = peak area of niacinamide from the Standard solution 

C_S = 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.

4.2 UNIFORMITY OF DOSAGE UNITS (905)

Meet the requirements

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers.

USP REFERENCE STANDARDS (11)

USP Niacinamide RS