Concept Life Sciences offers complete purity profiling and characterization for 5 batch analysis and preliminary analysis studies to GLP or non-GLP requirements for worldwide registrations. This includes optional impurity pre-screening.
Let us quickly identify and quantify your impurities
Concept is a specialist CRO focussed on problem solving and delivering high quality analytical and laboratory support. We use our extensive characterization of materials experience to our advantage when performing 5 batch analysis and purity profiling studies.
5 batch analysis and purity profiling studies can be challenging in terms of impurity detection and complexity. We use our unique blend and range of sophisticated analytical instrumentation to offer in-depth support, delivering to your exact needs.
When unknown impurities are complex to identify, we have the in-house capacity to isolate them (Mass-directed HPLC-Prep systems available in-house) and can quickly characterize the impurities for identification.
If not available commercially we can synthesize the impurities. Three state-of-the-art laboratories within the group are dedicated to compound synthesis.
Our highly-skilled scientists can also provide a complete Certificate of Analysis for the prepared compound, with complete characterization and quantification.
With expertise across many scientific disciplines, our dedicated team can also offer GLP Q-NMR for purity check or re-quantification of expired compounds. This is an accurate, time and cost-saving technique, enabling our customers to overcome complex challenges on your path to success.
5 batch analysis services
- Analytical profile of batches
- Active substance method development, validation & quantification
- Impurity method development, validation & quantification
- Preliminary analysis
- Complex and low-level contaminants, such as dioxins and furans, metals, solvents
- Determination of Water content
- Determination of Sulphated ash content
- Determination of the Loss on drying
- Other testing required according to the Active substance specifications
- Full GLP compliance for spectrometric characterization of the batches and impurities: 1H & 13C NMR, IR, MS, UV