02.18.15
SGS Life Science Services now offers a full range of analytical methods to identify amino acid impurities in pharma and biopharma manufacturing at its lab in Taunusstein, Germany, in line with the European Pharmacopoeia (Ph.Eur.) Qualification is expected in March 2015, with the amino acid analytical function fully operational by May 2015.
Analysis will be conducted in accordance with Ph.Eur. 2.2.56, Method 1 – Post-Column Ninhydrin Derivatisation, which was 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 by Ph.Eur. and employed at the SGS facility, utilizes spectrophotometry and liquid chromatographic techniques designed to provide greater resolution and sensitivity.
“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.”
Analysis will be conducted in accordance with Ph.Eur. 2.2.56, Method 1 – Post-Column Ninhydrin Derivatisation, which was 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 by Ph.Eur. and employed at the SGS facility, utilizes spectrophotometry and liquid chromatographic techniques designed to provide greater resolution and sensitivity.
“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.”