Unacceptable levels of nitrosamine impurities were first reported in June 2018.
Subsequently, other nitrosamine impurities have been detected in other drugs. Guidelines classify them as Class 1 impurities or mutagenic carcinogens and are classified as probable carcinogens by the International Agency for Research on Cancer (IARC).
LabAnalysis has already validated in-house methods (for the standard solution part) to be used depending on the sample type (API, tablets, injectable solutions, creams) for the determination of nitrosamines listed in the EMA guidelines.
LabAnalysis has a team of experts dedicated to the development of ad hoc methods for the determination of API-related nitrosamines. More than 20 methods for the determination of API-specific nitrosamines have already been developed.
Since 2018, FDA and EMA have defined the maximum limit of nitrosamines that can be contained in pharmaceutical products.
The guidelines classify them as carcinogenic impurities or mutagens and are listed as probable carcinogens by the IARC (International Agency for Cancer Research).
LabAnalysis has the best methods for the determination of nitrosamines in the EMA guidelines, as well as a team of experts researching ad hoc solutions for the determination of API-specific nitrosamines.
To date, more than 20 specific methods have been developed.
For further information on NitrosaminesContact Us