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Understanding Your API’s and Drug Products Physical Properties

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An understanding of the physical properties of your drug substance or product is an essential component to controlling and optimizing drug performance and manufacture.

Controlling and optimizing these properties will impact impurity profile and stability, distribution of materials in the drug product, aggregation and so much more.

Primera offers a variety of services to assist you in the determination of physical properties. Please keep reading to see how we can help you.

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Particle Size Analysis

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Primera utilizes the Malvern Mastersizer 3000 along with the Malvern Zetasizer nano to determine the particle size and the particle size distribution in your material.

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X-Ray Powder Diffraction (XRPD), per USP<941>, for qualitative analysis (Identification Test), or quantitative analysis (polymorph form content).

Fourier-Transform Infrared Spectroscopy (FTIR), per USP<197>, including KBr Disc and ATR (attenuated total reflectance) for identification test and structural characterization.

Differential scanning calorimetry (DSC), for melting point determination, and thermal phase transition analysis and characterization. 

Viscosity, for both Newtonian and non-Newtonian Liquids, including instrumentation with Capillary viscometer, Brookfield viscometer, and Anton Paar Rheometer.

Primera also provides wide range of other physical tests, including but not limited to:

  • Optical Rotation
  • Osmolarity
  • Turbidity
  • Density
  • Color and Achromicity
  • Hardness
  • Disintegration
  • Solubility
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