SGS rolls out latest Ph.Eur. amino acid impurities testing method at German lab

18-Feb-2015 - Last updated on 06-Dec-2023 at 11:37 GMT

SGS offers Post-Column Ninhydrin Derivatisation testing at German lab

SGS will soon be able to test up to 30 batches of amino acids for impurities per month after adding new analytical methods to those offered at its laboratory in Taunusstein, Germany.

The Swiss firm has added Post-Column Ninhydrin Derivatisation to its offering, citing the method’s inclusion in the latest edition of the European Pharmacopoeia (Ph.Eur.) and growing drug industry demand for more sensitive testing of ingredients and intermediates.

Spokesman Ferdinand Dabu told us testing amino acids requires a range of analysis methods including several used to detect impurities that have very similar chemical characteristics using ninhydrins.

“So-called ninhydrin positive substances have to be examined according to Ph.Eur. for amino acids used as raw material” he explained, adding that the new method replaces thin layer chromatography with more sensitive HPLC-based analysis.

Dabu said the Taunusstein lab will be able to “handle about 25-30 samples per month with turnaround times of 15 working days” when operational in May adding the qualification process required for the new method is expected to complete next month.

Germany

From a business perspective, SGS’s launch of the new method brings capabilities at the German lab into line with those already offered at its testing centres in Clichy, France in Warve, Belgium and Lincolnshire in the US.

According to SGS the Taunusstein lab is the only contract testing site to offer Post-Column Ninhydrin Derivatisation in Germany under cGMP.

Introduction of the new method is part of a wider programme of service expansion at SGS laboratories that includes a new lab in Carson, California, investment in vaccine testing at its facility in Glasgow, Scotland and getting its lab in Livorno, Italy cGMP accredited.

The firm is also moving its existing Clichy lab operation to a new site in the neighbouring town of Villeneuve la Garenne in a relocation project scheduled to complete sometime after March this year.