Do you test excipients and packaging materials?

Author : mahek dangi | Published On : 07 Nov 2026

Yes. Excipients should be evaluated because residual nitrites may react with amines and form nitrosamine impurities during manufacturing or storage. Sensitive nitrosamine analysis, nitrosamine detection, and nitrosamine testing can identify nitrites or related risks in excipients, raw materials, and recovered solvents. 

Packaging materials should also be included in the risk assessment. Certain packaging components may release nitrosamines or nitrites, which can transfer to the medicine. When a credible risk is found, suitable nitrosamine analytical testing or confirmatory testing of the finished product should be performed. 

Molkem provides professional nitrosamine analysis services for excipients, raw materials, intermediates and recovered solvents. Molkem also reviews packaging components to identify possible nitrosamine formation or carry-over risks and help determine the required testing approach. 

Conclusion: Excipients can be tested directly, while packaging materials should be assessed and tested when a potential nitrosamine risk is identified.