title: Amino acid analysis for pharmacopoeial purposes.
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.
authors.affiliation: University of Würzburg, Institute for Pharmacy and Food Chemistry, 97074 Würzburg, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Wahl
authors.affiliation: University of Würzburg, Institute for Pharmacy and Food Chemistry, 97074 Würzburg, Germany. Electronic address: ulrike.holzgrabe@uni-wuerzburg.de.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Holzgrabe
mesh_terms: D000596:Amino Acids / Q000032:analysis*; D004340:Drug Contamination
chemical_list: D000596:Amino Acids
keywords: Amino acids; Detection; Impurity profiling; Production; Separation