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Related Experiment Videos

Thermal analysis methods for pharmacopoeial materials.

D Giron-Forest1, C Goldbronn, P Piechon

  • 1Department of Pharmaceutical Chemistry, Analytical Research and Development, SANDOZ Ltd, Basle, Switzerland.

Journal of Pharmaceutical and Biomedical Analysis
|January 1, 1989
PubMed
Summary

Differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) offer simple, automated methods for purity and polymorphism studies. These techniques can replace traditional assays in pharmacopoeial monographs, enhancing quality control.

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Area of Science:

  • Analytical Chemistry
  • Materials Science
  • Pharmaceutical Analysis

Background:

  • Differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) are established techniques for material characterization.
  • Current pharmacopoeial methods for purity and solvent determination, such as melting point and loss on drying, have limitations.
  • Automation and robotics have increased the feasibility of using DSC and TGA for routine analyses.

Purpose of the Study:

  • To propose the integration of DSC and TGA into pharmacopoeial monographs.
  • To present DSC and TGA as alternatives or replacements for traditional pharmacopoeial assays.
  • To highlight the capability of these methods for polymorphism and purity determination.

Main Methods:

  • Differential scanning calorimetry (DSC)

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  • Thermogravimetric analysis (TGA)
  • Robotic automation for routine quality control

    • Main Results:

    • Demonstrated the suitability of DSC and TGA for purity and solvent determinations.
    • Showcased the application of these techniques for polymorphism studies and quantitative analysis.
    • Provided examples of DSC robotics used for quality control of pharmacopoeial raw materials.

    Conclusions:

    • DSC and TGA can serve as effective replacements for routine melting-point and loss on drying assays.
    • Incorporating DSC and TGA into pharmacopoeial monographs can improve the assessment of polymorphism and purity.
    • Automated DSC and TGA are valuable tools for routine quality control in the pharmaceutical industry.