5 Batch Analysis and Impurity Profiling
A GLP approved facility for 5 Batch Analysis of technical materials for an active ingredient, and relevant manufacturing impurities. At Oxford Analytical we have extensive knowledge and experience in this method.
The preliminary step is the determination of the analytical profile (screening).
Oxford Analytical Services Ltd offers a wide range of techniques to support identification of impurities. We can create a profile that means you can make an informed and well supported decision on the best way to proceed for your project.
We can support customers from small to large business, and work with a range of consultants. We would be happy to make recommendations for expert consultancy services to support your registration needs.
Once your impurity profile has been identified we can put together the 5-batch analysis project based on your registration requirements and specific compound needs.
This may include assay of active substance and impurities, as well as physical tests such as moisture content and sulphated ash.
We have specific equipment to work with manufacturing impurities such as solvents too.
Method validation would normally form an important part of this service and can be carried out to meet the requirements of SANCO/3030/99 rev.5.
We offer a service, which is fully GLP compliant and can be tailored to meet your specific requirements.
Please contact us for further discussion of your particular 5 batch analytical requirements.
Details of our work with Elemental Impurities (Heavy Metal Residues) – ICH guideline Q3d
Details of our work with 5 Batch Analysis and Impurity Profiling