The equipment is suited to analysis conforming to European Pharmacopoieal method 2.2.56, which was adopted in 2014.
Impurities have the potential to compromise the safety and efficacy of any medicine formulated with amino acids. A wide range of potential impurities exist and it is the so-called ninhydrin-positive substances (NPS) – a heterogenous group of known and unknown compounds - that this new equipment is dedicated to detecting.
RSSL uses ion chromatography to separate out the components of the test sample, and the IC technology is permanently linked to a reactor unit, in which ninhydrin is introduced, before passing the reagant compounds to a UV detection system. The detector is set to record primary and secondary amines, which absorb at different wavelengths in the UV spectrum (570nm and 440nm respectively). The test is sensitive to impurities at a threshold of 0.05%, as required by the EP monograph, and capable of determining whether the overall impurity level exceeds the limit of 0.5%.
"This equipment is dedicated to this single task of detecting impurities in amino acids," notes Ian Burrus who heads the service for RSSL. "It can also perform the ammonium standard test, as well as detecting the NPS, so gives our customers the assurance that the raw materials they are using are as pure as they can be. Many customers ask us to perform a verification step with their test material to demonstrate that the test is appropriate for their samples and we are happy to do this, as well as performing full-scale validation if required. Having this capability at RSSL further extends the range of GMP services that we can offer to the pharmaceutical and bio-pharmaceutical sectors.”
