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Amino Acid Analysis

GBA Pharma Labs - Amino Acid Analysis According to Ph.Eur. 2.2.56

Amino Acid Analysis According to Ph.Eur. 2.2.56

Due to their widespread usage, the determination of the purity of amino acids (testing for "substances detected with ninhydrin ") is one of the most common issues in pharmaceutical analysis. In the past, this test was carried out according to the guidelines in the individual monographs of amino acids, using thin-layer chromatography, in accordance with Ph.Eur. 2.2.27. In all of the European Pharmacopeia monographs on amino acids, this test is successively being converted from TLC testing to the use of an amino-acid analyzer (Ph.Eur. 2.2.56).

The corresponding specifications are described in the individual monographs in the European Pharmacopeia (Ph.Eur.), as in chapter 2.2.56, which describes the general methods for the determination of ninhydrin-positive substances (such as ammonium). GBA Pharma Labs have already developed special, verified methods for the testing of amino acids for ninhydrin-positive substances using an amino acid analyzer for every amino acid, and we work with the highest quality standards in this field for the benefit of our customers.

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GBA Pharma Labs – GMP Testing

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Particle Determination

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Elemental Impurities Testing

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GBA Pharma Labs - Amino Acid Analysis

Amino Acid Analysis

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Protein Characterization

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Limit test for DEG and EG by GC

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