According to USP 40 method, related compounds (organic acids) of alanine and aspartic acid should be analyzed using a column packed with L17. The system must have suitable resolution between maleic acid and malic acid, and each relative standard deviation of maleic acid, malic acid and fumalic acid (repeated six times). All conditions were satisfied when analyzed using SUGAR SH1011.
(Notice) Alanine and aspartic acid cannot elute under this analysis condition.
System suitability
Resolution (Maleic acid / Malic acid) |
Relative standard deviation (RSD) (each of Maleic aicd, Malic acid and Fumalic acid) |
|
Alanine | ≥ 1.5 | ≤ 5.0% |
---|---|---|
Aspartic acid |
≥ 1.5 | ≤ 10.0% |
Sample : 10μL
(a) Sysytem suitability solution for Alanine | (b) Sysytem suitability solution for Asparatic acid |
1. Maleic acid 0.05mg/mL | 1. Maleic acid 0.05mg/mL |
2. Malic acid 3mg/mL | 2. Malic acid 1.5mg/mL |
3. Fumaric acid 0.05mg/mL | 3. Fumaric acid 0.1mg/mL |
Column : Shodex SUGAR SH1011 (8.0mmI.D. x 300mm) Eluent : 0.008N H2SO4 aq. Flow rate : 0.6mL/min Detector : UV(214nm) Column temp. : 30°C