Cathy Dodge`s Blog Site

As part of a new drug development programme the stability of the active ingredient itself needs to be evaluated. It is important to ensure the drug is stable if possible and if not, what degradation products are formed.  stability studies are therefore essential. ICH guidelines recommend stability studies at increased temperature and relative humidity levels and this is available at Onyx Scientific. In addition forced degradation can also involve evaluating the photostability of a new drug. This is also conducted at Onyx Scientific in special photostability cabinets. Typically, samples are taken over defined periods of time and purity evaluated by methods such as HPLC.

This entry was posted on Saturday, August 21st, 2010 at 2:11 am and is filed under Business. Both comments and pings are currently closed.