5-Batch Analysis

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 programme that aims to establish how many impurities are present at a significant level and if required may try and identify such impurities.

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 present, whilst at the same time targeting previously unknown impurities. We often 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.

We offer a service, which is fully GLP compliant and can be tailored to meet 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 but are typically 4 to 8 weeks from receipt of samples to draft report stage.

We have a wealth of knowledge in five batch analysis from previous experience and an extensive range of successful historical product registration data.