What We Learned at The Nitrosamines Round Table Discussion
Posted on February 19th, 2020
Back in November, we wrote a short blog about nitrosamines and how it was likely to become the most pressing issue faced by the pharmaceutical industry in the new year. We touched upon some of the most pressing problems that those testing for nitrosamines would face along with some of the work we’d been developing with Dr Mark Harrison at AstraZeneca.
Mark has kindly agreed to present at the Nitrosamine meeting on analytical techniques he is using to combat the issues which are faced below.
Since then, we hosted a round table discussion with representatives from AstraZeneca, GSK and Pfizer sharing information on how each was approaching the issue. The idea was to come to some general consensus on the main challenges that need to be addressed.
Not only was it an engaging and enlightening day, but it felt important… just getting everyone in the same room and sharing information so freely was a pleasure to be a part of. I think we have a much better collective understanding of the kind of problems that will need solving.
In short, nitrosamines can very easily get into samples from a variety of common materials present in most labs – nitrile gloves used in the handling of samples being the most obvious example. Pipette tips could also be a potential issue. The potential for false positives is important since even low levels will cause significant headaches. Fortunately, much of these risks should be alleviated by automating the sample preparation.
There is concern that some samples analysed can degrade in solution to produce nitrosamines (false positives). By dissolving samples at the time of injection, this greatly reduces this possibility.
Detection of nitrosamines in drug products will be a challenge for the pharmaceutical industry due to the high level of excipients present. The excipients can cause ion suppression effects which could lead to poor detection limits of certain nitrosamines.
At Anatune, we have the capability to reduce excipient levels by introducing solid phase extraction (SPE) and liquid-liquid extraction.
The sheer number of samples that will need to be reliably tested is huge. Robust (possibly complex) sample preparation methods will need to be fast and run 24-7.
There are generally two methods in common use at the moment. A German LC-MS method represents about 50% of the market. This one is favourable because it makes testing for NMBA much easier. FDA GC-MS makes up the other 50%. Both will have to be thoroughly and equally accounted for.
These issues are what we’ll be getting to the bottom of on the 2nd of April. Mark Harrison has kindly agreed to present at the event and it’s already filling up fast.