The particle size distribution of active ingredients and excipients is an important physical property of materials used to manufacture pharmaceutical products. The size, distribution and shape of the particles will affect the overall performance, stability and appearance of the final product. Therefore, particle size monitoring is essential for the entire drug development and manufacturing process.
Fig.1 Particle morphology (Shekunov B Y, et al. 2007).
CD Formulation can provide you with comprehensive particle size analysis services of active ingredients and excipients, and our scientists will help you to make a decision for operational and procedural conditions that can ensure the physical and chemical stability and pharmacological activity of the product to minimize potential formulation and stability issues.
Technique | Method | Effective Measuring Range, μm | Most Representative PSD |
Optical image analysis | Direct imaging | 3 - 150 | Number-weighted |
SEM | Direct imaging | 0.01 - 150 | Number-weighted |
LD | Low-angle (Fraunhofer) diffraction rings measurement | 0.5 - 1,000 | Volume-weighted |
DLS | Measurement of light intensity correlations from particles in Brownian motion | 0.003 - 3 | Volume-weighted |
Coulter counter | Electrical zone-sensing | 0.6 - 1,200 | Volume-weighted |
TOF | Measurement of particle velocity in expanding air flow | 0.5 - 200 | Number-weighted |
CI | Inertial particle impaction as a function of air velocity | 0.5 - 10 | Mass-weighted |
SEM: Scanning electron microscopy; LD: Laser diffraction; DLS: Dynamic light scattering; TOF: Time-of-flight; CI: Cascade impactor.
If you have a requirement about particle size analysis services, please contact us by phone or email, our colleagues will reply to you within three working days.
References
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