Analysis

Analysis

Almac’s analytical team deploys a wide range of capabilities to analyse your product. We routinely develop methods in-house, or work with and adapt your existing methods as required.

We issue Certificates of Analysis specifying batch number, identity, results of analyses, GMP status, and retest date. Stability studies are fully compliant with ICH standards.

Techniques

  • We are experienced in working with a wide range of analytes. Almac staff are experienced in method development, and able to quickly develop and validate a method to analyse customer material
  • Existing analysis methods can be efficiently transferred to our facility, and verified for use with radiolabelled analytes
  • HPLC systems with radioflow, UV and fluorescence detection
  • Mass spectrometry available for stable and radio-labelled products
  • Radio-TLC using Cyclone Phosphor Imaging system
    • Gravimetric
    • Mass Spectrometric
  • Specific activity determination
  • NMR (500 MHz)
  • LC-MS, LC-MS-MS, and GC-MS for accurate determination of isotopic enrichment
  • X-Ray Powder Diffraction (XRPD)
  • Particle Size analysis (microscope)
  • GC for residual solvents
  • SDS-PAGE

Stability studies

We routinely conduct stability studies, ranging from short and informal, through to detailed studies over long periods, carried out to ICH standards.

  • Validated –80°C stability storage facility for radiochemicals
  • Storage at 2-8°C, -20°C
  • 25°C/60%RH, 30°C/65%RH, 40°C/75%RH stability chambers for stable-labelled materials

Stability and storage units are continuously monitored and connected to a Building Management System to ensure continuity of service.

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