From April 2020 all marketing authorisation holders of medicines containing chemically synthesised APIs must conduct a nitrosamine risk assessment
As the European Medicines Agency (EMA) risk assessment deadline draws near, Ellutia’s total nitrosamines pre-screening solution 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.
The US FDA has also already acted to call in various drugs known as ARBs for testing
Andrew James, Marketing Director at Ellutia, said: “Measuring apparent total nitrosamine content (ATNC) provides a benchmark of the nitrosamine volume in a product. Rather than embark on a lengthy analytical process to deliver detailed and speciated results in the first instance, the ATNC method screens only for the total nitrosamine content, both volatile and non-volatile compounds, and returns an analysis with a single clear peak.”
“Any sample found to contain an ATNC outside the safe level can be red flagged and sent for further analysis by a TEA interfaced to a GC or HPLC to individually identify the species and quantify the presence of nitrosamines such as NDMA,” James added.
James explained that the risk assessment requirement from the European medicines agency means that pharmaceutical manufacturers need to take a serious look at potential nitrosamine contamination in their product lines. He added that in America, too, the US Food and Drug Administration (FDA) has also already acted to call in various drugs known as ARBs for testing.
Ellutia Chromatography Solutions will present its solution for pharmaceuticals at Analytica, hall A2, stand 329, Analytica, 31st March – 3rd April, Munich.