Wide Range of Analytical Services for Drug Product Development

Chemical analysis and development of methods to identify, characterize and test materials is an essential part of drug product development. Pensatech Pharma offers the necessary range of analytical equipment and method development expertise to support your drug substance, excipients and drug product testing requirements.

Development, optimization and validation of physicochemical and pharmaceutical analytical methods:

  • Compendial methods
  • Non-compendial methods
  • In-house developed methods
  • Customer-supplied methods

Capabilities

Conventional and sophisticated testing equipment is available to characterize APIs, excipients and drug products by several 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 of powders and granules (compaction simulator)

Drug release studies

  • USP dissolution testing
  • Franz diffusion cells
  • Sirius Inform
  • In-house designed release devices (e.g., oral cavity, nasal, ophthalmic DDS)

Additional capabilities

  • 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 solubility and solution stability

Analytical methods development and validation

  • Dissolution
  • Assay
  • Content uniformity
  • Impurity
  • Water content
  • Solvent residuals

Additional capabilities

  • Optimisation and validation of not well performing analytical methods
  • In process controls/ physical characterisation of dosage forms and API/ excipients
  • API-excipient compatibility studies

Please get in touch to discuss your next pharmaceutical project with Pensatech Pharma

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