Stability studies, stress tests and forced degradation tests are a critical component of drug development for the assessment of drug storage or shipment conditions, expiration date, and packaging. In fact, they provide a thorough understanding of the chemical behavior, degradation pathways and the intrinsic stability of a new molecule. Therefore, to accelerate the registration process of a new drug product or substance, stability and forced degradation studies should be performed as early as possible in the drug development process.
At CARBOGEN AMCIS AG, we can perform forced degradation tests, stress tests, and stability studies according to the International Conference on Harmonisation (ICH) guidelines.
Stability StudiesOur stability studies are performed in fully GMP validated and mapped stability chambers, which operate at ICH conditions and at low temperatures.
Storage Conditions for walk-in and reach-in chambers
- 25°C / 60% r. H.
- 30°C / 65% r. H.
- 40°C / 75% r. H.
- 30°C / 75% r. H.
- - 20°C
- - 80°C
ICH Stability Studies
- Customized studies
Forced Degradation Studies & Stress Tests
Our forced degradation studies and stress tests encompass stress testing under acid or alkaline conditions, oxidative stress testing, and photostability studies. Based on the innovatorís specific needs, we can develop and tailor stability studies as well as forced degradation tests at any stage of the drug development.
- Heat and humidity
- Customized studies
- Stability indicating method
Integrated Analytical Services
The degradation products deriving from stress studies can be isolated and fully characterized by means of our extensive in-house analytical tools. Our integrated analytical services for drug substances and products are designed to flexibly support our customersí requirements. We offer support in method development and validation, solid state characterization, crystallization development, and preformulation studies with the aim to accelerate registration applications for new drug products and substances and to enhance time to market.
To ensure sample and data integrity, the chamber conditions are monitored 24 hours a day, seven days a week. In the case of an unlike technical failure, an on-site emergency power supply and a solid business continuity plan minimize the time during which conditions may be out of range. Stability data acquisition, evaluation and monitoring are tracked via computer-based systems compliant with the latest FDA standards (21CFR Part 11). Additionally, our Laboratory Information Management System (LIMS) ensures that all requested tests are performed on time and allow our customers direct, real-time access to important samplesí analytical information with the highest level of access security.