SGS introduces amino acid analysis services at Taunusstein, Germany
Uses spectrophotometry and liquid chromatographic techniques for greater resolution and sensitivity
SGS Life Science Services, a testing and certification company, is now able to offer a full range of analytical methods to identify amino acid impurities within pharmaceutical and biopharmaceutical manufacturing at its laboratory in Taunusstein, Germany.
The facility is said to be the only contract lab in Germany able to offer these services under GMP.
Analysis will be conducted in accordance with the European Pharmacopoeia (Ph.Eur.) 2.2.56, Method 1 – Post-Column Ninhydrin Derivatisation, which began to be rolled out 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, uses spectrophotometry and liquid chromatographic techniques for greater resolution and sensitivity.
SGS anticipates that qualification will be completed next month, with the amino acid analytical function fully operational by May.
The new service in Germany complements SGS’ existing amino acid analytical services provided from its laboratories in Clichy, France, Wavre, Belgium and Lincolnshire, US.
'As many pharmaceutical companies only buy one or two batches of amino acid per year, it would not be feasible for them to carry out this analysis in-house,' said Dr Sheida Hoenlinger, Director, SGS Life Science Services Germany.
'With the addition of GMP amino acid analysis at our Taunusstein facility, we are now able to offer our German and global customers an integrated service for the entire respective amino acid monograph.'
