According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (PF 48(4)*), mannitol assay should be carried out with an HPLC and a column filled with L22 packing material, and meets following requirements. The use of SUGAR SP0810, a sugar analysis column, confirmed the requirements were met.
System suitability requirements:
Tailing factor: ≤ 2.0
Relative standard deviation (RSD): ≤ 2.0%
*The version at the time of the application acquisition.
Sample : 80 μL
1. USP Mannitol RS 2.5 mg/mL
Column : Shodex SUGAR SP0810 (8.0 mm I.D. x 300 mm) Eluent : H2O Flow rate : 1.0 mL/min Detector : RI Column temp. : 80 ℃
