In recent years, regulators globally have introduced increasingly stringent regulations that require increasing quality standards in the pharmaceutical industry. In this context, attention towards stress tests conducted on active pharmaceutical ingredients and formulated products has increased significantly.

Stress testing is a procedure that allows you to examine the degradation of an API by exposing it to more severe conditions than those of normal use. LabAnalysis, with its vast experience in hundreds of stress tests and the help of cutting-edge technologies, is able to conduct any type of stress test, adhering to national and international regulations (AIFA, FDA, ANVISA).

To implement stress tests, LabAnalysis Life Science uses:

• Use of the best advanced technologies for the qualitative and quantitative evaluation of active pharmaceutical ingredients and their degradation products.
• Numerical evaluation and rational discussion of mass balances.
• Transfer of analytical methods by adapting them to mass spectrometers to obtain structural information on the main degradation products.
• Isolation and characterization of the most representative impurities by NMR.
• Sharing the results obtained with the client and including a final report.