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Related Experiment Videos

Quantifying amorphous content of lactose using parallel beam X-ray powder diffraction and whole pattern fitting.

X Chen1, S Bates, K R Morris

  • 1Department of Industrial and Physical Pharmacy, School of Pharmacy and Pharmacal Sciences, Purdue University, 1336 RHPH, West Lafayette, IN 47906, USA.

Journal of Pharmaceutical and Biomedical Analysis
|July 14, 2001
PubMed
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This study shows parallel beam X-ray powder diffraction (XRPD) and whole pattern fitting accurately quantify amorphous content in pharmaceuticals. This method reliably detects low levels, down to 0.37% amorphous lactose.

Area of Science:

  • Pharmaceutical Analysis
  • Materials Science
  • Crystallography

Background:

  • Quantifying amorphous content in pharmaceutical solids is crucial for drug stability and efficacy.
  • Traditional X-ray powder diffraction (XRPD) methods can be limited by sample height artifacts.
  • Accurate detection of low amorphous content is essential for quality control.

Purpose of the Study:

  • To evaluate parallel beam XRPD combined with whole pattern fitting for quantifying residual amorphous content in pharmaceutical solids.
  • To demonstrate the advantages of parallel beam optics over Bragg-Brentano optics for XRPD analysis.
  • To establish the sensitivity and reproducibility of the method for amorphous content determination.

Main Methods:

  • Lactose monohydrate was mixed with varying amounts of amorphous lactose.

Related Experiment Videos

  • X-ray powder diffractograms were recorded using parallel beam XRPD.
  • Whole pattern fitting analysis was performed using specialized software (Kratos Analytical Inc.).
  • A normalization technique was applied to account for tube fluctuation effects.

    • Main Results:

    • Parallel beam XRPD eliminated sample height artifacts observed with Bragg-Brentano optics.
    • Whole pattern fitting reproducibly predicted amorphous lactose content between 1-10%.
    • The limit of detection for amorphous content was determined to be 0.37%.

    Conclusions:

    • Parallel beam XRPD with whole pattern fitting offers accurate quantification of low amorphous content in pharmaceuticals.
    • The method is more robust against sample variations compared to traditional XRPD techniques.
    • This approach enhances the quality control of solid pharmaceutical dosage forms.