5 Batch Analysis, Screening & Impurity Profiling
5 Batch Analysis of technical materials for the active ingredient and relevant manufacturing impurities is where we have extensive knowledge and experience.
The preliminary step is the determination of the analytical profile (screening) which may be carried out by Oxford Analytical Ltd., or if already available, this information may be provided by the client.
If reference standards for any of the identified impurities are not commercially available, we can assist with organising custom synthesis through a specialist third party.
Following on from this it would be usual to proceed to the full analysis of the five product batches for purposes of obtaining registration.
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.4.
We offer a service, which is fully GLP compliant and can be tailored to meet your specific requirements. The timelines for completion of a five batch study with validation and impurity assay can vary depending on the complexity of the study, however we will always endeavour to meet your registration needs and understand this can mean short turnaround times.
Where possible we may be able to provide a dedicated team to work on your project in order to achieve this.
We have a wealth of knowledge in this area from previous experience and from an extensive range of successful historical product registration data.
Please contact us for further discussion of your particular 5 batch analytical requirements.