Nitrosamine & NDSRI Testing
Nitrosamine risk assessment and testing require sensitive analytical methods capable of addressing very low concentration limits and compound specific concerns.
Teleios supports analytical investigations for small molecule nitrosamines and nitrosamine drug substance related impurities.
What We Can Support
- Method development
- Confirmatory testing
- Targeted nitrosamine analysis
- NDSRI investigations
- Sensitivity and selectivity optimization
- Product and process investigations
- Analytical troubleshooting
Typical Analytical Questions
- Is a nitrosamine present?
- Can the method reach the required sensitivity?
- Could the drug substance or process generate an NDSRI?
- Does an observed signal require confirmation?
Analytical Approach
Methods are developed for the specific analyte and matrix, with attention to sensitivity, selectivity, and avoidance of in situ formation during sample preparation and analysis.
Regulatory & Compendial Framework
Depending on the program, material, and intended use, studies may consider:
- FDA Control of Nitrosamine Impurities in Human Drugs
- FDA recommendations for acceptable intake limits for NDSRIs
- Current FDA nitrosamine acceptable intake information
- ICH M7(R2), where relevant to mutagenic impurity risk assessment
- Applicable regional regulatory expectations
Not every listed framework applies to every study. Applicable expectations depend on product type, development stage, route of administration, material, intended use, and jurisdiction.