UPDATE on angiotensin II receptor blocker (ARB) recalls - FDA publishes LC-HRMS and RapidFire-MS/MS testing methods to provide options for regulators and industry to detect nitrosamine impurities – Drug Information Update

UPDATE on angiotensin II receptor blocker (ARB) recalls - FDA publishes LC-HRMS and RapidFire-MS/MS testing methods to provide options for regulators and industry to detect nitrosamine impurities – Drug Information Update

FDA published two new testing methods, the LC-HRMS method and the RapidFire-MS/MS method, to provide options for regulators and industry to detect nitrosamine impurities in ARB drug substances and drug products.

The LC-HRMS method can detect N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), N-Nitrosodiisopropylamine (NDIPA), N-Nitrosoethylisopropylamine (NEIPA), and N-nitrosodibutylamine (NDBA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).

The RapidFire-MS/MS method can detect NEIPA, NDIPA, NDBA, and NMBA. We do not recommend using this method to detect NDMA or NDEA because it is less sensitive to those impurities.

The LC-HRMS and RapidFire-MS/MS methods are the first methods FDA has posted for detecting NMBA. The European Directorate for the Quality of Medicines (EDQM) has also published methods to detect NDMA and NDEA . FDA has not validated EDQM's methods.

For more information, please visit: ARB Recall Updates.