Amino Acid Analysis
Analysis of amino acids
Amino acids are important structural components and are found in all living organisms on earth. Together with RNA, they are involved in protein biosynthesis. Amino acids are linked together to form peptides and proteins. In this process, amino acids are linked together to form peptides and proteins. They also have a variety of physiological effects on our bodies, such as neurotransmitters and hormones.
Amino acids have become indispensable in the biochemical-biopharmaceutical sector and are used, for example, in cell cultures in culture media, as therapeutics and for the production of proteins. As a result of their use in the pharmaceutical industry, it is essential that these substances are subject to efficacy and safety testing.
Identification in accordance with chapter Ph. Eur. 2.2.56.
In recent years the EDQM has worked intensively on the analysis of amino acids and has initiated a number of changes. Identity testing by a thin-layer chromatography method has been replaced by a more advanced test using liquid chromatography with post-column derivatisation. Today, with a few exceptions, the specific amino acid monographs of the European Pharmacopoeia describe a determination using the newly established method for the parameters 'ninhydrin-positive substances' and 'ammonium'. A separate general chapter, Ph. Eur. 2.2.56., gives detailed requirements for the procedure for this analysis of amino acids, with prior hydrolysis of proteins if necessary.
GBA Pharma Labs has experts with the necessary sensitivity for the instruments and redundant amino acid analysers (e.g. SYKAM Aminosäureanalysator S433) to perform the analysis described in the European Pharmacopoeia Chapter 2.2.56.
Verified monographs
In order to ensure quality control in accordance with the European Pharmacopoeia, it is necessary to carry out a verification for the analysis of 'ninhydrin-positive substances' and 'ammonium'. This analysis has been established at the GBA Pharma Labs site in Neuried and verified for the monographed amino acids (see table below). As a result, the analyses can be started quickly after the order has been placed and the time-consuming verification process has been completed beforehand. The verification documentation is available for your review.
Overview of verified amino acids
- Arginin HCl (01/2017:0805 corrected 10.0)
- Alanin (01/2017:0752)
- Arginin (01/2017:0806)
- Aspartic acid (01/2018:0797)
- Cysteine HCl H2O (01/2017:0895 corrected 10.0)
- Cystine (01/2019:0998)
- Glycine (01/2017:0614 corrected 10.3)
- Histidine (01/2017:0911)
- Histidine HCl H2O (01/2017:0910 corrected 10.0)
- Isoleucine (01/2017:0770)
- Leucine (01/2017:0771)
- Lysine Acetate (07/2023:2114)
- Lysine HCl (01/2017:0930)
- Magnesium-aspartate 2H2O (01/2018:1445 corrected 10.0)
- Phenylalanine (01/2017:0782)
- Proline (01/2017:0785)
- Serine (01/2017:0788)
- Threonine (01/2017:1049)
- Tryptophane (01/2017:1272)
- Tyrosine (01/2017:1161)
- Valine (01/2017:0796)
Was the required amino acid not listed?
Please do not hesitate to contact us and we will be happy to work on a solution for your analytical question. We are constantly expanding the list of verified amino acids.
The following aspects were generally checked during verification:
- System suitability tests according to Ph. Eur: Verification of compliance with the specific system suitability required in the individual monographs
- Selectivity
- Precision
- Reference solution (ammonium, proline, associated reference solution a)
- Spiked test solution (known impurity or unknown impurity)
- Sensitivity (determination of limit of detection and limit of quantitation)
- Stability of solutions
Proteins and Peptides
In addition to the direct analysis of amino acids, this method can also be used to measure proteins and peptides. The peptide bond is opened by hydrolysis to obtain amino acids. This hydrolysis can be carried out under the influence of pressure and temperature. We prefer to use modern methods using microwave digestion to open peptide bonds.
Required amino acid not monographed in the pharmacopoeia?
That's no problem. We are happy to develop a suitable analytical method based on the chapter Ph. Eur. '2.2.56 Amino Acid Analysis' and subsequently validate it according to ICH Q2.
We are pleased to have aroused your interest in our services. Please contact us with your analytical question and we will be happy to work on a solution.
