Chemical Stability should be one the first concerns in the timeline of product development. We offer a full variety of stability tests trying to use a generic approach for stress testing.

1. Preliminary chemical stability tests in early stages of discovery. Chemical stability prediction.
2. Complete stress studies of active substances and drug products, in order to force degradation and stablish the suitability of the analytical method as an stability indicating method.
3. Complete set of temperature and humidity controlled ICH compliant stability protocols.
4. Photostability studies.
5. Excipient compatibility studies.
6. Extractables and leachebles (E&L) in pharmaceutical packaging materials. We offer different approximations to deal with the determination of E&L, HPLC with an ultraviolet (HPLC-UV) or mass spectrometer (LC-MS) detector and GC-MS are the most specific methods for this purpose. When metals are a concern, we derive analysis to expert  inductively coupled plasma teams.