Stability and stress testing according to ICH guidelines

Chiracon provides comprehensive stability and stress testing services for active pharmaceutical ingredients (APIs) and intermediates, fully aligned with ICH guidelines (Q1A–Q1E). Our state-of-the-art facilities and expertise support forced degradation studies, long-term, accelerated, and photostability testing to generate robust data for regulatory submissions, shelf-life determination, and impurity characterization.

We design customized stability protocols tailored to your project's needs, including real-time and stress conditions to identify degradation pathways and critical quality attributes. Advanced analytical methods—such as HPLC, GC, and mass spectrometry—enable precise monitoring of purity, potency, and degradation products, with full documentation compliant with EMA and FDA expectations.

Chiracon’s dedicated stability team ensures seamless integration with your CMC development, offering flexible study durations, interim reporting, and expert interpretation to mitigate risks and accelerate timelines. This service positions Chiracon as your trusted partner for reliable stability data that supports clinical trials, commercial registration, and post-approval commitments.