Stress Test

Over the last few years, authorities around the world have applied increasingly stringent rules requiring higher quality standards. In this context, the stress tests performed on active pharmaceutical ingredients and formulated products demands a major attention.

Stress testing is a procedure that makes it possible to study the degradation of an API and/or pharmaceutical product by subjecting it to conditions that are worse than those of normal use.

After hundreds of stress tests, and with the support of state-of-the-art instrumentation, LabAnalysis is able to perform any type of stress test, based on national and international regulations (AIFA, FDA, ANVISA).

To perform stress tests, LabAnalysis makes use of:

Use of the best state-of-the-art 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 of the main degradation products obtained
Isolation and characterisation of the most representative impurities by NMR

At the end of the process, LabAnalysis shares with the customer the results obtained and the technical process followed to obtain them. A final report is drawn up.

Market

Stress Test