Products and services

Analytical services

Particle characterisation

Many pharmaceutical materials (APIs, excipients, intermediates and formulated products) are in solid form, and this can be the case whether the product is a liquid (for example a nasal suspension) or a solid (e.g. tablets). The physical and chemical properties of these solids and the particles from which they are made will greatly affect the behaviour of the materials during processing and also the stability of the product and its efficacy in the body.

LGC has considerable experience and expertise in the application of a broad range of specialised techniques to the characterisation of pharmaceutical materials in the solid state. These include:

  • Particle size distribution
  • Analysis of particle shape and aggregation
  • Surface area determination
  • Pore size distribution
  • Image analysis
  • Polymorphism using powder x-ray diffraction, infrared spectroscopy, Raman spectroscopy and thermal analysis
  • Elemental microanalysis using SEM/EDX
  • True density
  • Tapped and bulk density
  • Infra red and Raman microspectrometry
  • Thermal properties (thermogravimetric analysis, differential scanning calorimetry)

In addition to delivering the above measurements on a routine basis LGC has carried out many studies for our clients including:

  • Distribution of API in formulated drug product
  • Characterisation of polymorphic form in API and drug product
  • Development and validation of particle size and surface area methods for batch release
  • Comparison of APIs produced at different manufacturing sites

Our laboratories have been inspected by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) and the United States Food and Drug Administration (FDA) for GMP compliance.

Our technical expertise, combined with modern instrumentation and detailed knowledge of the regulatory requirements of the pharmaceutical sector, makes us an ideal partner for particle characterisation studies

 

 

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Contact details

For more information, contact

Madhu Mittra
+44 (0)20 8943 7580
pharmaceuticals@lgcgroup.com

General:
+44 (0) 208 943 7000
info@lgc.co.uk