Field of Experience

European Pharmacopoeial Amino Acid Analysis of Ninhydrin-Positive Substances

Since many years, European Pharmacopeia prescribed a method for determination of quality of high purity amino acids based on TLC and ninhydrin spray detection which might seem an easy and effective method, but prone to misinterpretation, resulting in low accuracy. Nowadays, as better techniques for determination of impurities are available by means of automated amino acid analyzers, EDQM started updating monographs by replacing the TLC method with a method for amino acid analysis called “ninhydrin-positive substances” and “Ammonium” test. These methods allow accurate calculation of other amino acids as impurities and useful estimation of levels of ninhydrin-positive substances.

Ansynth Service B.V. is a recognized expert in the amino acid analysis field for 25 years and is therefore able to offer a solid and state of the art analysis, exactly according to the required EP monograph, analysis method 1, according to EP 2.2.56 while meeting specifications in EP 2.2.46. The used equipment complies the gold standard Biochrom 30 or 30+ equipped with lithium buffers to ensure maximum detection capacity and quality. An extensive system suitability test is performed, solutions and reference standards are always freshly prepared, exactly according to the applicable monograph and analysis results are vigorously judged and checked.

Would you like to analyse your high purity amino acid products and derive results that you can truly rely on? Then feel free to contact us and inquire for possibilities.