Pharmaceutical physical characterization of pharmaceutical active ingredients (APIs), excipients and formulated products.
Understanding the physical properties of pharmaceutical solid materials is key to successful drug and process development. These physical properties can have an impact on the material's bulk properties, product performance, processability, stability and product appearance.
Physical characterization services can assist with formulation or process development, quality control, GMP lot release testing, and investigational manufacturing troubleshooting. Applications include solid dosage forms, suspensions, particulates, gels and liquid emulsions. These services can be offered on a Research and Development support or as Good Laboratory Practive (GLP), Good Clinical Practice (GCP) or Good Manufacturing Practice (cGMP) compliant services.
Molecular level physical characterization:
Pharmaceutical particulate characterisation
The particle size distribution of APIs and excipients is an important physical characteristic. The size, distribution and morphology of the pharmaceutical particles can affect bulk properties, product performance, processability, stability and appearance of the end product.
Bulk material characterization:
Powder X-Ray Diffraction can be used to study API polymorphs using morphological pure references as a comparison for the product during the development process, or as a GMP QC or batch release test. The technique can also be used to monitor raw materials, excipients and finished products. Changes in the morphology of these solid pharmaceutical materials can influence the drug's bioavailability and efficacy.
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