The ATNA has the capabilities of simultaneously detecting all and any of the 27 nitrosamines listed in the EU Regulation (EC) No 26/2004 and the 250 Nitrosamines listed in the FDA guidelines. Typically this is performed by HPLC MS or GC MS however this approach has been shown to have issues with false positives and sensitivity.
The fully automated system allows for better safety, higher throughput, sensitivity and user-friendliness when measuring for apparent total nitrosamine content (ATNC)This quickly gives an accurate result for the total nitrosamine content of a sample, showing both volatile and non-volatile components. With all pharmaceutical manufacturers now required to conduct risk assessments to evaluate the possibility of nitrosamine impurities, The ATNA solution offers the pharmaceutical industry a simple, accurate, and reliable test. It produces a clear pass/fail result in, allowing samples to be immediately cleared for processing or sent for further speciated testing. The Ellutia ATNA helps pharmaceutical manufacturers to meet the requirements of the EMA risk assessment without needing to outsource testing of raw materials or of products at different stages of manufacturing.
Nitrosamines are classified as probable human carcinogens and are one of the biggest issues currently facing the pharmaceutical industry. The ATNA is transforming nitrosamine testing as its high sensitivity and selectivity makes it ideal for detecting extremely low levels of nitrosamines. It is speeding up identification with its automated system, meaning companies are able to run more samples in a day with more accuracy and more confidence in the results. With the enormous workload generated by the regulatory requirements, the ATNA is helping companies ensure the can reach compliance in much more timely and cost effective manner.
