Material Characterization

Measuring and describing the properties of a material play an essential role from early development to quality control processes during production. You need material characterization to collect polymorph data showing that your API exhibits the intended behavior. You also need to identify drug product excipients to ensure batch consistency.

While good material characterization will identify and resolve process-related problems, inadequate material characterization can lead to unreliable product quality. This can manifest as inconsistent results during a clinical trial, leading to missed milestone targets from out-of-specification results at release or on stability. In production, this deficiency may require a complete redesign of the process.

The methods used to study and characterize your small or large molecule are complex. At Cambrex, our team of experts has the technical experience to run sophisticated analyses and the expertise to interpret the results. Your molecule is our mission.

Our material characterization capabilities include:

Thermal Analysis

Characterize loss of mass, phase transitions, melting points, stability and purity analysis using differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA).

Particle Size Determination

Analyze particle size using laser diffraction to ensure that active and excipient materials maintain expected processing and performance characteristics.

X-Ray Powder Diffraction

Detect, identify and quantify polymorph impurities (polymorphic screening) in support of process chemistry, API manufacturing, release and stability, using X-ray powder diffraction (XRPD).

Elemental Impurities

Test for elemental impurities using redundant inductively coupled plasma-mass spectrometer (ICP-MS), with microwave digestion available.