Analytical Method Development and Validation

Identification, Development, Monitoring and Quality Control Testing of your Product

Our scientists recognise that successful development programmes begin with a thorough understanding of the physico-chemical characteristics of the API, and any potential stability or excipient incompatibility challenges.

Analytical Research and Development

Using a range of techniques including, DSC / TGA, XRPD, Microscopy, FTIR, Particle sizing. etc. we gain fundamental understanding and insight into the behaviours and of your API and support the development activities required to support First in Human studies and product development.

Analytical and QC Services

Once your product enters clinical development our dedicated team of analytical experts work with you and our cross functional teams to transfer, development, and phase appropriate validation of your analytical methods and performance of QC and release testing including:

    • Assay, Content uniformity and related substances by HPLC
    • Performance testing including Dissolution and Disintegration
    • Moisture and residual solvents
    • IC Stability testing
    • Cleaning verification
    • DoE studies to investigating critical process parameters

Analytical Techniques

  • Differential Scanning Calorimetry (DSC)
  • Thermal Gravimetric Analysis (TGA)
  • Dynamic Vapour Sorption (DVS)
  • X-ray Powder Diffraction (XPRD)
  • Scanning Electron Microscopy (SEM)
  • Raman Spectroscopy
  • High Performance Liquid Chromatography (HPLC)
  • Liquid Chromatography – Mass Spectrometry (LCMS)
  • Ultra Violet Gas Chromatography (UVGC)
  • Fourier-transform Infrared Spectroscopy (FTIR)
  • Karl Fischer
  • Dissolution Apparatus I and II
analytical services HPLC

Stability Testing (ASAPprime®)

Early data read outs on the stability of both the API and early formulations can be used to provide early indications on potential stability issues, vital information that can save time and money in the development pathway.

ASAPprime® has been incorporated into our development programme as a critical, early stage analytical tool for identifying potential stability issues

Analytical Services Information Sheet

Download now to learn more about our analysis and testing services.

We’re here to help

If you’re looking to work with a CDMO that can support your product from preclinical development to market and beyond, then we’re here to help.
Speak to our team to discuss your requirements.

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