5 batch analysis

Concept Life Sciences offers complete purity profiling and characterisation 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 characterisation 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 characterise the impurities for identification.

If not available commercially we can synthesise 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 characterisation 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 characterisation of the batches and impurities: 1H & 13C NMR, IR, MS, UV

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