Mannitol USP

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

• USP Mannitol RS

ASSAY

• PROCEDURE

Mobile phase: Degassed water
System suitability solution A: 25.0 mg/mL each of sorbitol and USP Mannitol RS
System suitability solution B: 1.0 mg/mL each of maltitol and isomalt
Standard solution A: 50.0 mg/mL of USP Mannitol RS
Standard solution B: Dilute 2.0 mL of the Sample solution with water to 100.0 mL.
Standard solution C: Dilute 0.5 mL of Standard solution B with water to 20.0 mL.
Sample solution: 50.0 mg/mL of Mannitol

Chromatographic system (See Chromatography á621ñ, System Suitability.)

Mode: LC

Detector: Refractive index

Column: 7.8-mm × 30-cm; packing L19 Temperatures

Detector: 40° (maintain at a constant temperature)

Column: 85 ± 2°

Flow rate: 0.5 mL/min Injection volume: 20 µL

Run time: NLT 1.5 times the retention time of the mannitol peak.

[NOTE—The retention time for mannitol is about 20 min.]

The label states, where applicable, the maximum concentration of bacterial endotoxins. The label states, where applicable, that the substance is suitable for use in the manufacture of parenteral dosage forms.

Preserve in well-closed containers.