Material science testing by LGC

Our experience includes working with APIs, excipients, process impurities, degradation products and formulated products.

Techniques:

Physical Properties Testing

• Optical Microscopy
• Scanning Electron Microscopy (SEM) with Energy Dispersive X-ray (EDX)
• Particle sizing (Malvern and Sympatec: Wet and Dry methods)
• Particle shape by image analysis (QICPIC)
• Specific Surface Area by gas adsorption
• Inverse Gas Chromatography – Surface Energy Analysis (iGC-SEM)
• Dynamic vapour sorption
• Density (bulk and tapped)
• Sieve testing
• Porosity
• Dissolution

Solid Form Characterisation

• Powder X-ray diffraction
• Differential scanning calorimetry
• Thermogravimetric analysis
• FT-IR
• Thermo-microscopy
• Assessment of amorphous / crystalline form
• Determination of hydrates, solvates and co-crystals
• Crystal structure solution and solid form risk assessment

LGC has extensive experience in working with many product-delivery platforms and formulation types, and supports routine measurements, advanced characterisation, and bespoke method development and validation for all stages of your product development and manufacturing pipeline.

Applications

• Bulk powder handling and processing
• Solid form issues such as polymorphism, solvates, salts and co-crystals
• Chemical and physical stability
• Dissolution, crystallisation and segregation
• Compatibility between ingredients and packaging
• Polymer deformulation and glass delamination
• Pilot plant and commercial scale manufacturing
• Supplier change and raw materials evaluation studies
• Foreign particulates and contaminant identification
• Root cause analysis of API and drug product failures
• IP, patent litigation and counterfeits testing
• Due diligence activities for in-licensed compounds
• Analytical method transfer exercises