We can provide storage stability studies in support of registration.
We can offer a range of temperatures, conditions and lengths of storage to meet your requirements.
These testing packages use suitable methods of analysis such as CIPAC/OECD/EEC methods to comply with the appropriate regulatory authority guidelines.
Where these are not available standard in-house procedures are followed which are or can be fully validated. Alternatively, we offer project management services and work closely with 3rd party laboratories for any requirements that may be outside of our range of services.
We provide interpretation of the results and comparison with the appropriate regulatory guidelines.
If we do find a result which is outside a specified range, it is our policy to contact the client immediately whereupon the testing may be suspended, thereby avoiding any additional charges.
The range of tests employed is extensive and all tests are conducted by the staff of Oxford Analytical Ltd to the requirements of GLP where required.
We have also developed an in-house procedure to conduct assays on the effectiveness of cleaning procedures. This is now a registration requirement and our methodology can be adapted to cover your company’s recommended cleaning procedure.
We can also develop and validate methods for the Active Ingredient(s) and any relevant impurities as required.
Please contact us for a tailored quotation.