You wish to analyze and determine the NMBA (CAS: 61445-55-4) in your product?
NMBA, a chemical compound classified as a hazardous substance
To begin with, 4-(N-methylnitrosamino) butyric acid, NMBA, is a molecule belonging to the nitrosamine family.
Moreover, NMBA, like all nitrosamines, has been classified as a hazardous and potentially carcinogenic substance for humans by the IARC and the WHO.
Thus, nitrosamines are also monitored by the ANSM (Agence nationale de sécurité du médicament et des produits de santé) which conducts further studies on the risks associated with the presence of nitrosamines in drugs.
Indeed, the decree of October 2, 1997 limits the use of certain forms of nitrosamines, including NMBA, by indicating the tolerated residual quantity and, in some cases, the indicative dose of incorporation.
FILAB, laboratory for the analysis and determination of NMBA in industrial products
In order to support manufacturers in the development and quality control of their products, by following the regulatory changes, the laboratory provides a state-of-the-art analytical park, allowing the determination of NMBA and its precursors in trace amounts, in all types of matrices (food, pharmaceutical, cosmetic, polymer, water…).
The analysis are performed by, among others, the LC-MSMS technique.
The detection limits for NMBA vary from 1 to 10µk/kg (ppb) depending on the type of matrix.
FILAB also offers specific method development or method validation (ICH Q2) for NMBA determination on your matrices.
