Nitrosamines risk assessment - RSSL expert view

New regulations are prompting pharmaceutical manufacturers to examine their products more closely for signs of nitrosamine formation.


Here our nitrosamine expert Daniel Nicolau takes us through new and existing concerns, including updated EMA guidelines, appropriate testing methods and RSSL's bespoke method development and validation.


Learn more about our nitrosamine testing services here


Video transcript


The regulatory authorities have in recent years asked the industry to risk assess and evaluate all pharmaceutical products for the presence of Nitrosamines. Nitrosamines as a class of compounds are highly toxic and as such the authorities have set very low analytical thresholds and specialised analytical equipment is required, specifically Mass Spectrometry.


Here at RSSL we use an LC-MS Triple Quad to achieve those thresholds. In conjunction with our analytical analysis we use sample preparative techniques such as SPE and Liquid Liquid Extraction dependent on each analytical product that we test.

Our approach is to utilise a Limit Test Method Validation, it allows results to be given more quickly to the client. If however Nitrosamines are detected in the product we can re-validate quantitatively for that specific product.

In addition to LC-MS we utilise GC-MS, Direct Injection and GC-MS Headspace as alternative analytical techniques dependent on the requirements of each analytical product.


Because we are analysing a wide variety of products the formulations can be complex and difficult

and challenging and therefore each sample prep and method will be different and bespoke to each product. The regulatory authorities have identified six main Nitrosamines that require the risk assessment, however based on your assessment if any other Nitrosamines may be present those must be analysed and determined.


The FDA provided a guidance analytical method namely an LC-MS, however here at RSSL we have optimized that method to meet the very low threshold required.

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