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SGS Life Science Services adds analytical methods to identify amino acid impurities in bio/pharmaceutical manufacturing at facility in Germany.
SGS Life Science Services has announced that it offers analytical methods, in line with the European Pharmacopoeia (Ph.Eur.), to identify amino acid impurities in bio/pharmaceutical manufacturing at its laboratory in Taunusstein, Germany. The facility is the only contract lab in Germany able to offer these services under GMP, the company reports.
Analysis will be conducted in accordance with Ph.Eur. 2.2.56, Method 1 – Post-Column Ninhydrin Derivatisation, which started in January 2014. Ninhydrin is a reagent used to derivatise amino acids and was traditionally tested using thin layer chromatography, combined with visual and qualitative determination. The newer method, outlined in Ph.Eur.’s most recent edition and employed at the SGS facility, utilizes spectrophotometry and liquid chromatographic techniques for greater resolution and sensitivity.
SGS anticipates that qualification will be completed in March 2015, with the amino acid analytical function fully operational by May 2015. The capabilities in Germany complement SGS’ existing amino acid analytical services provided from its laboratories in Clichy, France, Wavre, Belgium, and Lincolnshire, IL.
Source: SGS Life Science Services