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Pharmaceutical Characterization

Micromeritics Predictive Materials Science Solutions for the Identification and Control of Critical Quality Attributes

Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control. Achieving QbD requires an in-depth understanding of physicochemical properties.

Early identification of Critical Quality Attributes (CQA) of excipients and active pharmaceutical ingredients (API) and their impact on a formulation is a key component of QbD. Micromeritics’ instruments and contract analytical services offer solutions for the early identification of CQA’s, continuous process monitoring, and verification, which are the foundation of QbD. Historically, particle size has been the dominant physical characteristic control parameter for release. But now, properties such as surface morphology, porosity, particle shape, density, and surface energy are additionally utilized as predictive tools to reduce possible manufacturing failures by predicting scale-up effects on the final product.

Backed by Micromeritics with over five decades of experience, The Particle Testing Authority (PTA)  will be your trusted materials characterization solution for pharmaceutical materials, medical devices, nutraceutic and other FDA-regulated products. Through the use of advanced analytical testing systems, PTA provides solutions for the optimization of your drug development and production processes.

Early identification and understanding of Critical Quality Attributes (CQAs) are essential steps in the process. From a QbD perspective, scientists, researchers, and regulators look for consistency, both in physical and chemical attributes. PTA is here to help you define, specify, and control the critical quality attributes of your materials.
Our areas of expertise include particle size distribution analysis (micrometer and nano particles), particle shape and morphology, surface area, surface energy, vapor sorption, porosity, density, thermal analysis, and material flow properties.

Micromeritics Material Science Solutions:

  • Streamlining Pharmaceutical Development
  • Identification/Evaluation of API, Excipient, and Blended Material Critical Quality Attributes
  • Providing Predictive Tools and Lab Services for Implementing QbD and PAT initiatives in line with ICH Q6A, Q8, Q9, and Q10 Guidelines
  • Using Materials Science to Model and Predict Material Behavior
  • Characterization Solutions for Robust Quality Control
  • Raw Material Qualification
  • Assessing Lot-to-Lot Variability
  • Assistance in Quality Investigations and CAPAs (Corrective and Preventative Actions)

Method Development / Validation

  • Method Development Services for all analytical tests
  • Method Validation Services for all analytical tests
  • Method transfer documentation
  • Secure Method and Validation storage for future projects

Analytical Services

  • Particle Size, Particle Shape (Light Scattering, Dynamic Light Scattering, Electrical Sensing Zone, Dynamic Image Analysis, Microscopy)
  • Surface Area(Gas Adsorption, BET)
  • Density (True, Apparent, Bulk, TAP, Carr index)
  • Porosity (Gas Adsorption, Mercury Porosimetry)
  • Thermal Analysis (DSC/TGA)
  • Dynamic Vapor Sorption (DVS)
  • Volumetric Vapor Sorption
  • Surface Energy (IGC)
  • Surface Energy (Volumetric Gas Adsorption-Density Functional Theory)
  • Zeta Potential

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Characterization of Powders and Porous Materials with Pharmaceutical Excipient Case Studies