5 Batch Analysis, Screening & Impurity Profiling
The preliminary step is the 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 (at cost) 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 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.
Please note that we are unable to perform 5 Batch Analysis to meet Brazilian guideline requirements.