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.

Our services

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

Want to find out more?

Our multi-disciplinary teams mitigate risk by employing knowledge, foresight and thought leadership to all our client’s diverse programs enabling the highest chance of success. Get in touch to find out how we can support you.