Amino acid analysis for pharmacopoeial purposes

Talanta
Oliver Wahl, U Holzgrabe

Abstract

The impurity profile of amino acids depends strongly on the production process. Since there are many different production methods (e.g. fermentation, protein hydrolysis or chemical synthesis) universal, state of the art methods are required to determine the impurity profile of amino acids produced by all relevant competitors. At the moment TLC tests provided by the Ph. Eur. are being replaced by a very specific amino acid analysis procedure possibly missing out on currently unknown process related impurities. Production methods and possible impurities as well as separation and detection methods suitable for said impurities are subject to this review.

Related Concepts

Drug Impurity
Thin Layer Chromatography
Fermentation
Analysis
Detection
RNA Chemical Synthesis

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