Niacin 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

Niacin Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of niacin (C₆H₅NO₂).

2 IDENTIFICATION

Change to read:

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

Sample: Heat a portion of finely powdered Tablets, equivalent to 500 mg of niacin, with 25 mL of alcohol on a steam bath for a few min. Filter, and wash the residue with a few mL of hot alcohol. To the filtrate add 30 mL of water, and evaporate to 25 mL on the steam bath. Cool, filter if insoluble matter separates, and evaporate the filtrate to 10 mL. Cool, and place in a refrigerator for 1 h. Filter the separated niacin with suction, wash it with a few mL of cold alcohol, and dry at 105° for 1 h.

Acceptance criteria: Meet the requirements

Change to read:

B. ^▲SPECTROSCOPIC IDENTIFICATION TESTS (197), Ultraviolet-Visible Spectroscopy: 1970 _{▲(CN 1-MAY-2020)}

Medium: 6.8 mg/mL of monobasic potassium phosphate in water, adjusted to a pH of 7.0 with 50% sodium hydroxide solution

Sample solution: 20 µg/mL in Medium from the Sample obtained in the Identification test A

Acceptance criteria: Meets the requirements in the chapter. The A₂₃₇/A₂₆₂ ratio is 0.46-0.50. 

C. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

PROCEDURE

Solution A: 5-mM solution of sodium 1-hexanesulfonate in water

Mobile phase: Methanol, acetonitrile, glacial acetic acid, and Solution A (14:7:1:78)

Standard solution: 0.050 mg/mL of USP Niacin RS in water. Dissolve with the aid of heat in a steam bath.

Sample solution: Transfer an equivalent to 500 mg of Niacin from NLT 20 finely powdered Tablets to a suitable flask. Add 50 mL of water, and heat on a steam bath for 30 min. Sonicate for 2 min, shake by mechanical means for 15 min, and cool to room temperature. Dilute with water to 0.050 mg/mL, and filter.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 262 nm

Column: 4-mm x 30-cm; packing L1

Flow rate: 1.3 mL/min

Injection size: 20 µL

System suitability

Sample: Standard solution

Suitability requirements

Column efficiency: NLT 1000 theoretical plates for the analyte peak

Tailing factor: NMT 2.0 for the analyte peak

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of niacin (C₆H₅NO₂) in the portion of Tablets 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 Niacin RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

4.1 DISSOLUTION (711)

Medium: 0.1 N hydrochloric acid; 900 mL

Apparatus 1: 100 rpm

Time: 60 min

Standard solution: 0.02 mg/mL of USP Niacin RS in the Medium

Sample solution: Filtered portion of the solution under test, suitably diluted with the Medium if necessary

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV

Analytical wavelength: Maximum at about 260 nm

Analysis

Samples: Standard solution and Sample solution

Determine the concentration of niacin in the Sample solution in comparison with the Standard solution.

Calculate the percentage of the labeled amount of niacin (C₆H₅NO₂) dissolved:

                         Result = (C x D x V/L) x 100

C = determined concentration of niacin in the Sample solution (mg/mL)

D = dilution factor for the Sample solution

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: NLT 65% (Q) of the labeled amount of niacin (C₆H₅NO₂) is dissolved.

4.2 UNIFORMITY OF DOSAGE UNITS (905)

Meet the requirements

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed containers.

USP REFERENCE STANDARDS (11)

USP Niacin RS