In pharmaceutical development, Particle Size Distribution (PSD) is a critical quality attribute—especially for Active Pharmaceutical Ingredients (APIs). Among the PSD parameters, D50 (also known as median particle size) plays a pivotal role.
What is D50?
D50 represents the particle size below which 50% of the sample’s volume (or weight) lies. In simpler terms, it’s the midpoint of your particle size population.
Why is D50 Important?
- It directly influences drug dissolution, bioavailability, and content uniformity.
- Helps control processability in granulation and compression.
- Key for ensuring lot-to-lot consistency during manufacturing.
Optimizing D50 means better control over:
- Solubility & Absorption (especially for BCS Class II/IV drugs)
- Flow properties and blend uniformity
- Stability and shelf-life of the final dosage form
From R&D to commercial manufacturing, monitoring and optimizing D50 ensures quality, performance, and regulatory compliance.
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