Riboavin 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

Riboflavin Tablets contain NLT 95.0% and NMT 115.0% of the labeled amount of riboflavin (C₁₇H₂₀N₄O₆).

2 ASSAY

Riboflavin Assay 〈481〉, Chemical Methods, Procedure 1

Sample solution:

Transfer a portion of the powder from NLT 20 finely powdered Tablets, equivalent to 20 mg of riboflavin, to a 250-mL flask, and add 150 mL of 0.1 N hydrochloric acid. Shake vigorously, and wash down the sides of the flask with sufficient 0.1 N hydrochloric acid to ensure that the pH remains below 1.5 during the subsequent period of heating. Heat the mixture on a steam bath, with frequent agitation, until the riboflavin has dissolved, or in an autoclave at 121° for 30 min. Cool, and with vigorous agitation, adjust the mixture with 1 N sodium hydroxide to a pH of 5–6. Transfer to a 1000-mL volumetric flask, and dilute with water to volume. If the solution is not clear, filter through paper known not to adsorb riboflavin. Dilute an aliquot of the clear solution with water to a final volume that contains 0.1 µg/mL of riboflavin.

Analysis: Proceed as directed in the chapter.

Calculate the percentage of the labeled amount of riboflavin (C₁₇H₂₀N₄O₆) in the portion of Tablets taken:

Result = (Iᵤ / Iₛ) × (Cₛ / Cᵤ) × 100

Iᵤ = corrected fluorescence value from the Sample solution

Iₛ = corrected fluorescence value from the Standard solution

Cₛ = concentration of USP Riboflavin RS in the Standard solution (µg/mL)

Cᵤ = nominal concentration of riboflavin in the Sample solution (µg/mL)

Acceptance criteria: 95.0%–115.0%

3 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: Water; 900 mL

Apparatus 2: 50 rpm

Time: 45 min

Standard solution: Known concentration of USP Riboflavin RS in 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 1.40 mg/mL of sodium 1-hexanesulfonate

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 3.9-mm × 30-cm; packing L1

Flow rate: 1 mL/min

Injection volume: 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 riboflavin (C₁₇H₂₀N₄O₆) dissolved:

Result = (rᵤ / rₛ) × (Cₛ × D × V / L) × 100

rᵤ = peak area of riboflavin from the Sample solution

rₛ = peak area of riboflavin from the Standard solution

Cₛ = concentration of USP Riboflavin 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 riboflavin (C₁₇H₂₀N₄O₆) is dissolved.

Uniformity of Dosage Units 〈905〉

Meet the requirements.

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

USP Reference Standards 〈11〉

USP Riboflavin RS