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- Active Ingredient / Impurity Analysis
- Active Ingredient Profiling
- Five Batch Analysis
- Method Development and Validation
- Physical and Chemical Analysis
- Product Formulation
- Residue Analysis and Field Studies
- Storage Stability Studies
Active Ingredient Profiling
Initially we would develop methods for the determination of the active ingredient and screening for any significant impurities within the technical material. We offer a screening program that aims to establish how many impurities are present at a significant level and if required may try and identify such impurities using our previous expedience and both LC-MS and GC-MS. Also can also provide a project management service in conjunction with 3rd party laboratories in order to provide a greater opportunity to identify the impurities by NMR and LC-MS-MS, we can then also obtain synthesized impurity standards from these same laboratories.
A typical screening procedure would include an initial assay of a single batch by HPLC-UV. Following on from this, further investigation may be conducted by GC-MS and/or LC-MS, which can often provide useful data on the tentative identification of organic impurities. Often these techniques can save time and associated costs by avoiding assays for impurities that are not significant, whilst at the same time targeting previously unknown impurities. We sometimes find the discovery of a previously unknown impurity can make up the shortfall in obtaining closure of a technical material profile.
Screening would be followed by the 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 for both the active ingredient and any relevant impurities.