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.