According to the United States Pharmacopeia and the National Formulary (USP 41-NF 36*), analysis for the assay of maltitol should be carried out with a 10-cm column filled with L34 packing material and meets following requirements. The SUGAR SP0810 8C, a 10 cm version of the SUGAR SP0810 designed for this analysis confirmed the requirements were met.
System suitability requirements:
1. Maltitol assay
(i) For standard solution
Relative standard deviation (RSD) of maltitol: ≤ 2.0%
(ii) For system suitability solution
Resolution of maltitol and sorbitol: ≥ 2.0
2. Maltitol solution
(i) Maltitol and sorbitol in standard solution
Tailing factor: ≤ 1.2
Relative standard deviation (RSD): ≤ 2.0%
*The version at the time of the application acquisition.
Sample : 10 μL
(Standard solution)
Maltitol 10 mg/g, Sorbitol 1.6 mg/g
(System suitability solution)
Maltitol, Sorbitol 4.8 mg/g each
1. Maltitol
2. Sorbitol
Column : Shodex SUGAR SP0810 8C (8.0 mm I.D. x 100 mm) Eluent : H2O Flow rate : 0.5 mL/min Detector : Shodex RI (35 ℃) Column temp. : 60 ℃
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