Total Nitrosamine Testing for Pharmaceuticals Introduced

摘要

As the European Medicines Agency(EMA)risk assessment deadline takes hold,Ellutia's total nitrosamines pre-screening solution offers the pharmaceutical industry a simple,accurate and reliable test.This delivers a clear pass/fail result for apparent total nitrosamine content(ATNC)in minutes,allowing samples to be immediately cleared for processing or sent for further testing.From April 2020,all marketing authorisation holders of medicines containing chemically synthesised active pharmaceutical ingredients(APIs)must conduct a risk assessment to evaluate the possibility of nitrosamines being present.Any sample showing an ATNC below the World Health Organisation(WHO)'s specified interim limit cannot possibly contain any one nitrosamine above the total level,and so can be deemed safe.The Ellutia ATNC test is based on the 800 Series Thermal Energy Analyser(TEA)interfaced to a unique chemical stripping system.It allows pharmaceutical manufacturers to meet the requirements of the EMA risk assessment without needing to outsource testing of raw materials or of product at different stages of manufacturing.