Reading Scientific Services Ltd (RSSL) has expanded its pharmaceutical assessment capabilities with the introduction of a robust analytical method designed to determine the presence of nitrosamines. Using highly-sensitive mass spectrometers in conjunction with a range of separation techniques, the new service can not only reach exceptionally low regulatory thresholds, but also accommodate a wide variety of pharmaceutical products and active species.

The move enables the scientific consultancy to respond to urgent market demand for greater nitrosamine testing capacity, as Dr Daniel Nicolau, Senior Scientist for RSSL explains:

“With regulators stipulating that all required analytical testing for nitrosamines must be completed within the next two years, pharmaceutical manufacturers are under significant pressure - particularly given that an extensive and technically challenging analysis may be needed.

“With this in mind, we have developed a single, overarching analytical method to successfully overcome the complexities of the process and provide much-needed support to the sector. It gives us the flexibility to tailor our approach according to individual client requirements - both in terms of the product and target nitrosamines - and still meet all the necessary regulatory demands.”

RSSL’s technical experts use an integrated state-of-the-art triple quadrupole liquid chromatography-mass spectrometer (LC-MS) to detect specified nitrosamines across a range of complex product formulations. While the application of techniques, such as solid-phase extraction (SPE) and liquid-liquid extraction, ensures the sample preparation is fit for purpose.

“Separating low levels of nitrosamine from a high concentration of API and excipients is far from straightforward due to the many chemical and physical properties that must be taken into account. That’s why we work closely with our clients to develop and validate a bespoke analytical method, using the maximum daily dose of their product and the safety concern threshold. In this way, we are able to deliver the information they need to demonstrate compliance with the latest nitrosamine regulations,” adds Nicolau.

RSSL’s new nitrosamine testing service is part of its comprehensive range of critical assessment services for pharmaceutical products which also includes Extractables and Leachables studies and Impurity investigations.

Watch our Nitrosamines Risk Assessment interview with Daniel Nicolau here: https://www.youtube.com/embed/NP3Nx86llfk