According to the United States Pharmacopeia and the National Formulary (USP 41-NF 36*), analysis for the sorbitol should be carried out with a 10-cm length column filled with L34 packing material and meets following requirements. The SP0810 8C, a 10-cm column of SUGAR SP0810, confirmed the requirements were met.
System suitability requirements:
Resolution of mannitol and sorbitol: ≥ 2.0
Relative standard deviation (RSD) of sorbitol peak area: ≤ 2.0%
*The version at the time of the application acquisition.
Sample : 10 μL
(System suitabilitysolution)
Mannitol, Sorbitol 4.8 mg/g each
(Standard solution)
Sorbitol 4.8 mg/g
1. Mannitol
2. Sorbitol
Column : Shodex SUGAR SP0810 8C (8.0 mm I.D. x 100 mm) Eluent : H2O Flow rate : 0.7 mL/min Detector : RI (35 °C) Column temp. : 50 °C
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