Material Characterization

Identification of materials often extends beyond chromatographic or Fourier transform infrared spectroscopy (FTIR) analysis.  Knowledgeable staff at Avista Pharma have the capabilities to execute material and polymorphic form identification utilizing Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA) and X-Ray Powder Diffraction (XRPD).  The capability to perform TGA-Gas Chromatography-Mass Spectrometry (TGA-GC-MS) is also available.

 

Thermal Analysis

DSC and TGA data are valuable techniques to determine stability, polymorphic form identification and monitoring, pre-formulation activities and release testing. TGA, or TGA-GC- MS, are powerful tools to perform investigations in support of drug substance and drug product manufacturing.

 

Particle Size Determination

Particle size is critical to ensuring materials maintain expected processing and performance characteristics.  Avista Pharma is equipped with laser particle size (LPS) instrumentation to ensure materials are consistent from batch to batch.  If further investigation is necessary, the capability to provide large population particle imaging with gallery and various size and shape morphology results is available.

 

X-Ray Powder Diffraction

XRPD is a straight forward analysis to perform polymorphic screening, process chemistry support, stability, release, and investigation studies.

 

In addition to specific method development and phase-appropriate validation methods, a list of the most common USP tests that we perform includes (note: EP tests available also):

USP <941> Characterization of Crystalline and Partially Crystalline Solids by X-Ray Powder Diffraction

USP <891> Thermal Analysis

USP <661> Containers – Plastics

USP <429> Light Diffraction Measurement of Particle Size