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Developing Robust PSD Methods via Laser Diffraction for Micronized Powders
Particle Size Distribution (PSD) is a critical material property that governs drug product performance, including dissolution rates, powder flow, and stability. While laser diffraction is the preferred industry technique, generating consistent data relies heavily on the quality of sample dispersion. This whitepaper provides expert guidance on selecting between wet and dry dispersion methods to ensure you are measuring primary particles, not agglomerates.
- Dispersion Selection: Learn to choose between dry and wet dispersion based on solubility, powder flow, and potency/toxicity requirements.
- Method Validation: Understand how to test for accuracy, repeatability, and robustness according to USP and European Pharmacopoeia standards.
- Visual Verification: Discover why optical microscopy is essential for verifying that agglomerates have been properly dispersed before laser analysis.