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Analysis of Maltitol According to USP-NF Method (SP0810 8C)


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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