In response to the new nitrosamines regulations, RSSL have extended their pharmaceutical risk assessment capabilities, developing a single, overarching analytical method to successfully overcome the complexities of the testing process and provide much-needed support to the sector
Utilising sensitive mass spectrometers and a range of separation techniques, RSSL can reach exceptionally low regulatory thresholds, accommodating a wide variety of products and active species.
This approach gives RSSL the flexibility to develop a bespoke nitrosamine analytical method for each client, in terms of both the product and target nitrosamines, while still meeting all the necessary regulatory demands.
As Dr Daniel Nicolau, Senior Scientist for RSSL explains: “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.”
Learn more from Dr Nicolau below:
RSSL have an array of testing techniques and equipment including:
o Headspace GC-MS
o Direct Injection GC-MS
RSSL’s new nitrosamine testing service is part of a comprehensive range of critical assessment services for pharmaceutical products which also includes Extractables and Leachables Studies and Impurity Investigations.
To find out more about the new nitrosamines testing service or to discuss your testing requirements with an RSSL specialist please email firstname.lastname@example.org or click here to visit the website.