In July 2018, the European Agencies and the FDA established strict limits for these potentially carcinogenic impurities, after being detected in active ingredients of the family of the “sartans”.
At present, the Agencies have established temporal limits that will be much stricter in 2021.
In addition to “sartans” family, levels of NDMA (N-nitrosodimethylamine) in ranitidine have recently been detected, so it will be necessary to look for levels of these impurities in many active ingredients.
What is needed for these studies?
To quantify nitrosamines, high sensitivity and specificity equipment are needed. These impurities can be quantified by mass detectors associated with liquid chromatographs (LC/MS) or gas chromatographs (GC MS).
In addition, it is necessary to develop and validate appropriate methods to detect nitrosamines in the different active ingredients.
What Netpharmalab offers to you…
At Netpharmalab we have both liquid chromatographs and gas chromatographs coupled to mass detectors, in order to detect and quantify nitrosamines at the levels required by the Agencies.
Currently, we have validated methods to quantify NDMA and NDEA within the limits required in 2021 by the Agencies (0.03 ppm for both impurities) in the active ingredients of the family of “sartans”.
In addition, we are constantly developing and validating new methods to quantify all nitrosamines in the rest of active ingredients, such as ranitidine.