Characterization of powder properties such as particle size distribution, particle shape (morphology), surface area, as well as bulk and tapped density is typically performed and monitored for Active Pharmaceutical Ingredients (APIs) in development and for release testing of commercial APIs, due to their impact on the performance and quality of the Drug Product (DP). Particle size and surface area for example are directly correlated to the dissolution rate of an API which, for poorly soluble drugs may impact bioavailability. The ability of a powder to be handled, to flow or be blended with other powders such as excipients may also be a determining factor for the quality and performance of a drug product, e.g. to ensure good content uniformity.

AMRI offers cGMP testing of particle properties using the following techniques:

  • Particle size analysis by laser light scattering, for the characterization of particles in the approximate size range ~0.01-3500 µm (dependent on dispersion unit and material evaluated). Development, transfer and/or validation of analytical methods are performed by experienced scientists following ICH and USP guidelines. Available instrumentation include:
    • Malvern Mastersizer 2000 with the following dispersion units for wet and dry methods:
      • Hydro 2000µP (wet)
      • Hydro 2000S (wet)
      • Hydro 2000SM (wet)
      • Scirocco (dry)
    • Malvern Mastersizer 3000 with the following dispersion units for wet and dry methods:
      • Hydro MV (wet)
      • Hydro SV (wet)
      • Aero S (dry)
  • Sonic sieving
  • Particle counter by light obscuration (AccuSizer particle counter and sizer)
  • Microscopy
  • Particle morphology and size range by image analysis
  • Scanning Electron Microscopy (SEM)
  • Surface Area and porosity analysis by BET technique
    • Micromeritics Gemini V and VII models
    • Micromeritics TriStar (N2 and Kr)
  • Bulk and Tapped Density

Read Press Release: AMRI’s SSCI Implements Next-Generation Analytical Instrumentation to Further Strengthen Particle Characterization Solutions