During the Nitrosamines and GTIs conference (Vienna, April 2025), we discussed that NDMA is a volatile nitrosamine and should therefore be handled with particular caution.
As a Finished Product (FP) manufacturer, we have typically outsourced such analytical activities. However, we are now considering initiating in-house analytical work for nitrosamines in several products, including those related to Metformin.
Are there any available publications or guidelines outlining the safety measures we should consider?
@elenipoliti This is a topic that has been really high in my list of concern when it comes to confirmatory testing. Countless times, I have seen nitrosamine reference materials being treated as any other reagent in the lab. We are talking about a highly potent impurity at a very high purity in the hands of the analyst.
Unless a lab is equip with the necessary infrastructure and appropriate SOP and training, analyst should not be handling solid nitrosamines reference materials.
I would like to invite @parthamuk2003@mayank.bhanti@jason.brown to share their perspective and experience in the lab operation when it comes to safety
in few words, the best solution is a dedicated laboratory equipped with fume hoods with glove-boxes, in order to avoid any possible contact with carcinogenic substances. We choose this solution.
(I do not know if a glove box may be installed in an existing fume hood).
If you cannot install a glove box, the best solution is the use of commercial diluted standards; even if they are still classified as carcinogens (H350), they are less dangerous than pure NDMA.
Of course you should discuss all the details with your HSE department.
kind regards
We are rather fortunate in that we already had a balance enclosure next to our LC-MS. So, standard preparations can occur there. This will need to be proceduralized. After that first dilution, the concern is minimal, as previously alluded to. Samples are not considered a primary concern due to the concentration within the sample.
