Mitigating the Risk of Nitrosamines in Pharmaceutical Drug Delivery Systems and Biomedical Devices

In the pharmaceutical industry, the presence of nitrosamines is a serious problem. To combat this, regulatory agencies have implemented strict requirements for the evaluation and control of these contaminants. Nitrosamines can originate from a variety of sources, including raw materials, manufacturing processes, and even water sources. Their detection requires sensitive analytical methods.

To comply with regulations, all approved drug products must undergo a nitrosamine risk assessment by November 2023 and confirmatory testing by August 2025. This requires the use of specialized analytical technology such as tandem mass spectrometry detectors combined with chromatographic separation, to get accurate results. Drug product sponsors are responsible for ensuring appropriate testing, so it is crucial to work with a contract development and manufacturing organization (CDMO) experienced in nitrosamine evaluation and testing.

A CDMO with extensive experience in nitrosamine testing can offer support in line with the latest guidelines and requirements. A partner that also provides a screening platform for rapid results on potential nitrosamine risks and has the necessary equipment, including mass spectrometry instruments, to support nitrosamine testing, is critical to ensuring the safety of your products for patients.