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.Maleic acid
- 2.Malic acid
- 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 ℃
Sample Name Index
Operation Manual / Certificate of Analysis
Operation Manuals and Certificate of Analysis / Inspection Certificate for the following products can be downloaded here.
Product Name Index
Applications
- Effects of Flow Rate (KC-811)
- Effects of Injection Volume (KC-811)
- Effects of Sample Load (KC-811)
- Effects of Column Temperature (KC-811)
- Effects of Concentration of Eluent on Elution Volume (KC-811)
- Effects of Column Temperature on Elution Volume (1) (KC-811)
- Effects of Column Temperature on Elution Volume (2) (KC-811)
- Effects of Acetonitrile in Eluent (1) (KC-811)
- Effects of Acetonitrile in Eluent (2) (KC-811)
- Effects of Reversed Phase Column on Elution Volume (KC-811 + DE-613)
- Elution Volume of Aromatic Organic Acids (NN-814)
- Elution Volume of Organic Acids (NN-814)
- Elution Volume of Organic Acids (DE-413)
- Comparison of Analysis of Organic Acids with 4 Kinds of Detectors (Standards) (KC-811)
- Comparison of Analysis of Organic Acids with 4 Kinds of Detectors (Soy Sauce) (KC-811)
- Influence of Acidic Eluent Selection on Organic Acid Analysis (KC-811)
- Organic Acid Standards (1) (KC-811)
- Organic Acid Standards (2) (KC-811)
- Organic Acid Standards (3) (KC-811)
- Organic Acid Standards (4) (DE-413)
- Organic Acid Standards (5) (DE-213)
- Citric Acid in Phosphoric Acid (DE-613 + KC-811)
- Analysis of Organic Acids in Beer (KC-811)
- Analysis of Organic Acids and Vitamin C in Fruit Juice (KC-811)
- Reverse Phase Analysis of Gluconic Acids (DE-613)
- Analysis of Organic Acids in Sake (Japanese Rice Wine) (KC-811)
- Analysis of Organic Acids in White Wine (KC-811)
- Analysis of Oxalic Acid Using Ion Exclusion Mode (KC-811)
- Organic Acid in Phosphoric Acid (DE-613 + KC-811)
- Analysis of Organic Acids in Soy Sauces (KC-811)
- Organic Acids in Vinegar (KC-811)
- Separation of Succinic Acid and Fumaric Acid (KC-811)
- Analysis of Organic Acids (Eluent Conteinig Cyclodextrin) (KC-811)
- Camphor and Benzoic Acid (NN-814)
- Di-carboxylic Acids (DE-413)
- Analysis of Organic Acids in Soybean Paste (KC-811)
- Analysis of Organic Acids in Soy Sauce For Noodles (KC-811)
- Organic Acids Analysis in Black-vinegar (KC-811)
- LC/MS Analysis of Organic Acids (DE-213)
- Simultaneous Analysis of Saccharides, Organic Acids and Amino Acids with LC/MS (VG-50 2D)
- Simultaneous Analysis of Hydrophilic Substances in Energy Drink with LC/MS (VG-50 2D)
- Organic Acids (KC-811)
- LC/MS Analysis of Pipecolic Acid (NH2P-40 2D)
- Elution Volume of Organic Acids (NI-424)
- Analysis of Povidone According to Pharmacopeia Method (KC-811)
- Analysis of Acetic Acid in Vinegar Drinks (KC-811)
- Citric Acid Analysis in Functional Beverage (KC-811)
- Organic Acid Determination Test for Glycerin Fatty Acid Esters According to Japan’s Specifications and Standards for Food Additives (SH1011) (SH1011)
- Analysis of Malic Acid According to USP-NF Method (SH1011)
