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

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.

*The version at the time of the application acquisition.

 

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: ≤ 5.0%
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%

Sample: 10 µL
(a) Sysytem suitability solution for Alanine

  1. 1.Maleic acid 0.05 mg/mL
  2. 2.Malic acid 3 mg/mL
  3. 3.Fumaric acid 0.05 mg/mL

(b) Sysytem suitability solution for Asparatic acid

  1. 1.Maleic acid 0.05 mg/mL
  2. 2.Malic acid 1.5 mg/mL
  3. 3.Fumaric acid 0.1 mg/mLCa2+
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 ℃

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