Application of laser particle size analyzer in tadalafil intermediates

1. Quality control of intermediate particles

Particle size distribution analysis: The particle size of tadalafil intermediate directly affects its solubility, reaction efficiency and bioavailability of the final drug. The laser particle size analyzer can accurately measure key parameters such as d(0.1), d(0.5), d(0.9) of the intermediate, characterize the particle volume distribution (such as 10%, 50%, 90% cumulative value), and ensure that the particle size range meets the process requirements.

Homogeneity assessment: Non-uniform particles may lead to incomplete reactions or the formation of impurities. The laser particle size analyzer detects the angular distribution of scattered light, identifies particle shape differences (such as non-spherical particles) and distribution abnormalities, and assists in optimizing synthesis conditions.

2. Process optimization and dispersion research

Dispersant selection: The dispersion state of the intermediate is crucial to the test results. Water or ethanol is required as the dispersion medium in the wet test (if other solvents are required, it must be customized). The laser particle size analyzer can evaluate the impact of different dispersants on particle agglomeration to avoid larger particle sizes due to poor dispersion.

Ultrasonic treatment optimization: During sample preparation, the default ultrasonic time is 5-10 minutes to disperse the particles. If the intermediate is easy to aggregate, the ultrasonic time or intensity can be adjusted, and the dispersion effect can be verified by a particle size analyzer.

3. Detect aggregation and abnormal particles

During the synthesis or drying process of intermediates, factors such as temperature and humidity may cause particle aggregation. The laser particle size analyzer can quickly detect such abnormal phenomena and analyze the degree of aggregation through the difference between the volume average particle size (D[4,3]) and the surface area average particle size (D[3,2]) to guide process improvement.

Summarize

The core of the application of laser particle size analyzer in tadalafil intermediates is to improve synthesis efficiency and product quality through precise control of particle size distribution. Combining process parameter optimization and dispersion technology research can significantly reduce batch-to-batch differences and lay the foundation for subsequent drug formulation development.This time Winner3003 is recommended for customers to measure tadalafil intermediate samples.

Measuring instrument information is as follows:

The video of measuring nanoparticles is as follows：