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.
- Preliminary chemical stability tests in early stages of discovery. Chemical stability prediction.
- 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.
- Complete set of temperature and humidity controlled ICH compliant stability protocols.
- Photostability studies.
- Excipient compatibility studies.
- 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.