Meglumine

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

Meglumine contains NLT 99.0% and NMT 100.5% of meglumine (C₇H₁₇NO₅), calculated on the dried basis.

2 IDENTIFICATION

A.

Sample solution: Transfer 250 mg to a dry, 50-mL centrifuge tube, add 500 mg of sodium metaperiodate, then add 5 mL of water rapidly in one portion. Allow to stand undisturbed.

Analysis: The solution instantly turns yellow, and heat is produced. The color then changes from deep yellow to orange-brown (rust), and after 20 min, the rust-colored solution is cloudy. Then add 2 mL of 2.5 N sodium hydroxide.

Acceptance criteria: The mixture turns bright yellow and becomes clear.

3 ASSAY

Procedure

Sample: 500 mg

Titrimetric system

Mode: Direct titration

Titrant: 0.1 N hydrochloric acid

Endpoint detection: Visual

Analysis: Transfer the Sample into a conical ask, dissolve in 40 mL of water, and add 2 drops of methyl red TS. Titrate with Titrant. Each mL of Titrant is equivalent to 19.52 mg of meglumine (C₇H₁₇NO₅).

Acceptance criteria: 99.0%–100.5% on the dried basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

5 SPECIFIC TESTS

Absence of Reducing Substances

Sample solution: 50 mg/mL

Analysis: To 5 mL of Sample solution add 5 mL of alkaline cupric tartrate TS, and heat to boiling.

Acceptance criteria: The color of the solution does not change.

Completeness and Color of Solution

Sample solution: 200 mg/mL

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: Vis

Analytical wavelength: 420 nm

Cell: 1 cm

Blank: Water

Analysis

Sample: Sample solution

Acceptance criteria: Absorbance is NMT 0.030.

 Loss on Drying 〈731〉

Sample: 1 g

Analysis: Dry the Sample at 105° to constant weight.

Acceptance criteria: NMT 1.0%

Melting Range or Temperature 〈741〉: 128°–132°

Optical Rotation, Specific Rotation〈781S〉

Sample solution: 100 mg/mL, undried, in water

Acceptance criteria: −15.7° to −17.3°

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.