Analytical Development

Chemical analysis and development of methods to identify, characterize and test materials is an essential part of drug product development. Pensatech Pharma offers a wide range of analytical services to support your drug substance, excipients and drug products testing requirements.

 

Capabilities

Conventional and sophisticated testing equipment is available to characterize APIs, excipients and drug products by compendial, non-compendial, in-house and customer-supplied methods:

 

  • Chemical Analysis

    • Spectroscopy (AA, UV-VIS, FTIR)

    • Liquid chromatography (HPLC, GPC)

    • pH, conductivity, optical rotation

    • SDS-PAGE / IEF

 

  • Solid State Characterisation

    • X-ray diffractometry

    • Thermal analysis (DSC, TGA)

    • Dynamic vapour sorption  (DVS)

    • Polarised light microscopy (incl. heating/ cooling stage)

 

  • Particle characterisation

    • Particle size (LD, PCS, Coulter counter)

    • Particle shape (Optical microscopy with image analysis)

    • Powder rheometry

    • LOD, Karl Fischer

    • Compressibility (Compaction simulator)

 

  • Drug Release Studies

    • USP dissolution testing

    • Franz diffusion cells

    • Sirius Inform

  • Mechanical property analysis (Instron, Texture analyzer)

  • Rheology / Torque rheometry

  • Surface tension / Contact angle

  • Optical microscopy with image and video analysis (incl. hot-/ freeze-drying stage)

  • Scanning electron microscopy with EDX

 

Applications

Analytical methods development, transfer and validation activities are offered in parallel to formulation and process development studies. Our capabilities comprise:

  • Preformulation – Excipient/ API characterization

    • Solubility, solid state form, particle properties, solid state and solution stability

 

  • Analytical methods development and Validation

    • Dissolution

    • Assay

    • Content uniformity

    • Impurity

    • Water content

 

  • Optimisation and validation of not well performing analytical methods

  • In Process Controls/ Physical characterization of dosage forms and API/ excipients

  • API-excipient compatibility studies

 

For further information on our analytical development services, please contact us.