Accredited to ISO 17025 standards, WMINOLAB operates as a trusted global partner in the Determination of Nitrosamines, Method Validation, and Risk Assessment services, leveraging its team of experts and state-of-the-art instrumentation
Nitrosamines are chemical compounds, generally containing the chemical structure N-N=O, and are classified as possible human carcinogens. Since these compounds damage DNA, they can be classified as genotoxic impurities
In July 2018, the European Medicines Agency (EMA) issued a safety alert regarding the detection of the carcinogenic impurity N-nitrosodimethylamine (NDMA) in products containing the active ingredient valsartan
Due to the fact that nitrosamines can form not only during the production process of some raw materials, but also in the presence of some solvents, agents and raw materials and carry a risk of contamination, it is requested that risk assessment studies be carried out by the authorities for all products
WMINOLAB creates a study plan based on the acceptable daily intake amounts defined by USFDA and EMA, taking into account the daily intake doses.
We develop and validate product-specific methods in accordance with ICH Q9 Quality Risk Management to provide efficient solutions for the detection of nitrosamines, which are particularly challenging to identify in pharmaceutical formulations due to matrix effects
Nitrosamine Impurities
NITROSAMINE RISK ASSESSMENT FOR FINISHED PRODUCTS AND RAW MATERIALS
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Production
Nitrosamine Impurities
Study Plan of Nitrosamine Impurities
Through Nitrosamine Determination, we offer:
- Identification and quantification of nitrosamine impurities in pharmaceutical products, raw materials, active pharmaceutical ingredients (APIs), and packaging materials
- Verification of regulatory compliance
- Method development and validation
- Enhanced product and patient safety
- Optimization of extraction procedures to achieve relevant Limit of Detection (LOD) and Limit of Quantitation (LOQ) levels in pharmaceutical products.