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A logical stepwise approach to laser diffraction particle size distribution analysis methods development and

D Barber1, J Keuter, K Kravig

  • 1Geneva Pharmaceuticals, Inc., a Novartis Company, Broomfield, Colorado 80038-0446, USA.

Pharmaceutical Development and Technology
|July 8, 1998
PubMed
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This study developed and validated efficient particle size distribution analysis methods for 58 pharmaceutical powders. The validated methods ensure reliable quality control through robust particle size analysis.

Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry

Background:

  • Accurate particle size distribution (PSD) is crucial for pharmaceutical product performance and quality.
  • Developing and validating robust PSD analysis methods can be time-consuming and resource-intensive.

Purpose of the Study:

  • To establish a logical, stepwise, and efficient approach for developing and validating PSD analysis methods.
  • To validate methods for 58 different pharmaceutical bulk powders.
  • To ensure the developed methods are suitable for quality control settings.

Main Methods:

  • Utilized image analysis for particle morphology.
  • Employed laser diffraction for PSD analysis, optimizing dispersion medium, concentration, sonication time, and stability.
  • Performed ruggedness validation across different days, instruments, and material lots.

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Main Results:

  • A relative standard deviation (RSD) below 20% for median volume diameters (d50) indicated method ruggedness.
  • Median volume diameter (d50) was sufficient for method validation across 58 powders.
  • Typical validation data for methyldopa, metoprolol tartrate, and metronidazole were presented.

Conclusions:

  • The developed approach rapidly generates valid and reproducible PSD analysis methodology.
  • The validated methods are suitable for routine quality control in pharmaceutical manufacturing.
  • Efficient validation of PSD analysis is achievable with a structured, stepwise approach.