N-Methyl-D-Glucamine (Meglumine) CAS 6284-40-8 Assay 99.0%~100.5% (Titration) Factory

Meglumine
C7H17NO5 195.21
D-Glucitol, 1-deoxy-1-(methylamino)-;
1-Deoxy-1-(methylamino)-D-glucitol [6284-40-8]
DEFINITION
Meglumine contains NLT 99.0% and NMT 100.5% of meglumine (C7H17NO5), calculated on the dried basis.
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.
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 flask, 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
IMPURITIES
Delete the following:
• HEAVY METALS <231>
Test preparation: Dissolve 1 g in 20 mL of water, add phenolphthalein TS, neutralize with 3 N hydrochloric acid, and dilute with water to 25 mL.
Acceptance criteria: NMT 20 µg/g• (Official 1-Dec-2015)
• RESIDUE ON IGNITION <281>: NMT 0.1%
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 Spectrophotometry and Light-Scattering <851>.)
Mode: Vis
Analytical wavelength: 420 nm
Cell: 1 cm
Blank: Water
Analysis
Sample: Sample solution
Acceptance criteria: Adsorbance 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°
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed containers.