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Following on from the high profile product recalls of Ranitidine and Metformin, regulatory bodies from around the world (including the MHRA and the FDA), have set an internationally recognised acceptable daily intake limits for nitrosamines. These regulatory bodies have also stipulated that all required analytical testing for nitrosamines must be completed within the next two years.
With this in mind, RSSL have extended their pharmaceutical risk assessment capabilities to respond to the urgent market demand for greater nitrosamine testing capacity.
As Dr Daniel Nicolau, Senior Scientist for RSSL explains:
“RSSL 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.”
Click on the below video to learn more from Dr Nicolau:
https://www.youtube.com/watch?v=NP3Nx86llfk
Utilising highly sensitive mass spectrometers and used in conjunction with a range of separation techniques, RSSL scientists are able to reach exceptionally low regulatory thresholds, accommodating a wide variety of pharmaceutical products and active species.
RSSL work closely with clients to develop and validate a bespoke nitrosamine analytical method, using the maximum daily dose of their product.
RSSL’s testing techniques and equipment include:
- LC-MS Triple Quadrupole instruments
- A High Resolution Mass Spectrometer
- GC-MS instruments including:
- Headspace GC-MS
- Direct Injection GC-MS
- GC-QTOF
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 enquiries@rssl.com or click here to visit the website.