According to the United States Pharmacopeia and the National Formulary (USP 40-NF 35*), "ASSAY" and "IMPURITIES: Related Substances" for "Trehalose" should be carried out with a column filled with L58 packing material. The SUGAR KS-801, a column filled with L58 packing material, confirmed the requirements were met.

System suitability requirementsASSAY
Relative standard deviation (RSD) (Standard solution): ≤ 2.0 %

IMPURITIES: Related Substances
Resolution between trehalose and maltotriose (System suitability solution): ≥ 1.5
Relative standard deviation (RSD) of trehalose peak (System suitability solution): ≤ 2.0 %

*The version at the time of the application acquisition.

Sample: 20 µL
(System suitability solution) 0.25 % each of Trehalose, Maltotriose and Glucose

1. 1.Maltotriose
2. 2.Trehalose
3. 3.Glucose