What is the ICH guideline for nitrosamines?

Author : mahek dangi | Published On : 07 Nov 2026

ICH M7(R2) is the main guideline used to assess and control nitrosamine impurities in pharmaceuticals. It focuses on DNA-reactive mutagenic impurities that may present a potential carcinogenic risk. Manufacturers must evaluate possible sources of nitrosamine formation, perform nitrosamine analysis, and control detected impurities within applicable acceptable intake limits. 

When a risk is identified, sensitive nitrosamine detection and confirmatory nitrosamine testing should be performed using a product-specific analytical method. Method validation should follow ICH Q2(R2), including specificity, accuracy, precision, range, and detection and quantitation limits. 

Molkem provides professional nitrosamine analysis services, including risk-evaluation support, analytical method development, validation, and confirmatory quantification for APIs, finished products, excipients, and intermediates. Its nitrosamine analytical testing capabilities support pharmaceutical quality and regulatory requirements.

Conclusion: ICH M7(R2) guides nitrosamine risk assessment and control, while ICH Q2(R2) guides analytical method validation. Current market-specific requirements from authorities such as the FDA or EMA must also be considered.