One of the most important physical characteristics of powder and dispersion samples is the particle size. The particle size distribution may be monitored for several reasons:
- Evaluation of the milling of your drug substance
- Monitoring the stability of your suspension
- Flowability of the powder blend used for capsule filling
At Anabiotec, we have a Malvern Mastersizer 2000 which uses the laser diffraction technique to measure the size of particles. A dispersed sample passes though the flow cell of the optical bench, where a laser beam illuminates the particles. A series of detectors accurately measure the intensity of light scattered over a wide range of angles. These data are then analyzed to calculate the size of the particles creating the scattering pattern. The particle size is reported as a volume equivalent sphere diameter. A D10, D50 and D90 value are reported. These represent the particle diameter values of 10%, 50% and 90% respectively in the cumulative distribution. The particle distribution graph can be used as a fingerprint for your batch.
Depending on nature of the sample, the dispersion can be controlled by different sample dispersion units. Our particle sizer is equipped with both wet and dry dispersion units. In this way, samples may be delivered in a suitable, stable state. The combination of the optical bench and the sample dispersion units allows us to analyze both powders and liquid samples with particle sizes ranging from 0.02 to 2000 µm.
Do you want to monitor the particle size distribution of your drug substance or product batches? Do you want to study aggregation phenomena in your dispersed sample? Anabiotec has the necessary equipment and expertise for you.