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

According to the United States Pharmacopeia and the National Formulary (USP 40-NF 35*), "IMPURITIES: Related Compounds" for "Alanine"  and "Aspartic acid" should be carried out with a column filled with L17 packing material. The SUGAR SH1011, a column filled with L17 packing material, confirmed the requirements were met.
(Note) Alanine nor aspartic acid will not be detected in this method.

System suitability requirementsFor Alanine
Resolution between maleic acid and malic acid (System suitability solution): ≥ 1.5
Relative standard deviation (RSD) of maleic acid, malic acid, and fumalic acid (System suitability solution): ≤ 5.0% each

For Aspartic Acid
Resolution between maleic acid and malic acid (System suitability solution): ≥ 1.5
Relative standard deviation (RSD) of maleic acid, malic acid, and fumalic acid (System suitability solution): ≤ 10.0% each

*The version at the time of the application acquisition.

Sample: 10 µL
(a) (Sysytem suitability solution for Alanine)
A mixture of 0.05 mg/mL of Maleic Acid and 3 mg/mL of Malic Acid and 0.05 mg/mL of Fumaric Acid in water
(b) (Sysytem suitability solution for Asparatic acid)
A mixture of 0.05 mg/mL of Maleic Acid and 1.5 mg/mL of Malic Acid and 0.1 mg/mL of Fumaric Acid in water

  1. 1.Maleic acid
  2. 2.Malic acid
  3. 3.Fumaric acid
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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