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Analysis of Related Compounds of Alanine and Aspartic Acid According to USP-NF Method (SH1011)

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According to the United States Pharmacopeia and the National Formulary (USP 40-NF 35*), analysis of alanine and aspartic acid, and their related compounds (organic acids) should be carried out with a column with L17 packing material and meets following requirements. The SUGAR SH1011 confirmed the requirements were met.

(Note) Alanine nor aspartic acid will not be detected in this method.

System suitability requirements for alanine:
   Resolution (maleic acid and malic acid): ≥ 1.5
   Relative standard deviation (RSD) for maleic acid, malic acid, and fumalic acid: ≤ 5.0%
System suitability requirements for aspartic acid:
   Resolution (maleic acid and malic acid): ≥ 1.5
   Relative standard deviation (RSD) for maleic acid, malic acid, and fumalic acid: ≤ 10.0%

*The version at the time of the application acquisition.


Sample : 10 μL

(a) Sysytem suitability solution for Alanine (b) Sysytem suitability solution for Asparatic acid
1. Maleic acid 0.05 mg/mL 1. Maleic acid 0.05 mg/mL
2. Malic acid 3 mg/mL 2. Malic acid 1.5 mg/mL
3. Fumaric acid 0.05 mg/mL 3. Fumaric acid 0.1 mg/mL
Column       : Shodex SUGAR SH1011 (8.0 mm I.D. x 300 mm) 
Eluent       : 0.008 N H2SO4 aq.
Flow rate    : 0.6 mL/min
Detector     : UV (214 nm)
Column temp. : 30 °C

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