Our company can analyze the particle size of APIs through a range of particle analysis techniques, including microscopy, spectroscopy, laser scattering, etc. The size range that can be analyzed ranges from nanometers to 3 millimeters or even larger particles. If you have any needs, please contact us.
Our Services
Particle size is an integral parameter in the production of active pharmaceutical ingredients (API). According to the requirements of different drug dosage forms, the particle size of API should be controlled in different particle size segments to achieve the maximum drug effect. The particle size of the API will affect the solubility, bioavailability, and stability of the drug. At the same time, the particle size distribution will also affect the characteristics of the drug such as fluidity, blending uniformity, and compressibility, which can also affect the safety and effectiveness of the preparation. Therefore, the particle size analysis of the API is very important for the development of the final pharmaceutical dosage form.
At our company, we use a range of particle analysis techniques, including microscopy, spectroscopy, laser scattering, and solid-state characterization, to determine the particle characteristics of API. Our services support formulation development, GMP quality control, GMP batch release testing, GMP drug stability studies, and investigative production troubleshooting.
Particle Size Measurement
We use various measurement techniques (such as sieving, laser particle size analysis, etc.) to analyze the particle size parameters of the particles of API, such as average particle size, median particle size, etc. This can help evaluate the physical properties of the drug substance and the factors that affect the performance of the drug product.
Particle Size Distribution Analysis
We measure the size distribution of API particles by using different particle size analysis instruments (such as laser particle size analyzer, optical microscope, etc.). This can help determine the physical properties of the API and its suitability for subsequent processing.
Our Methods
Sieve Analysis
This is a mechanical screening method in which a raw material drug sample is passed through a series of screens with different aperture sizes. The particle size distribution is determined based on the weight or percentage of particles that pass through the screens. Sieve analysis is suitable for analyzing relatively coarse particles.
Laser Diffraction
This is a commonly used particle size analysis method. It involves illuminating a sample with a laser beam and inferring the particle size distribution based on the angle and intensity of scattered light. This method is suitable for samples with a wide range of particle sizes.
Microscopy Analysis
This method involves using a microscope to observe and measure particle sizes. It requires the preparation of thin slices or suspension samples. It is suitable for analyzing smaller particles.
Dynamic Light Scattering
This method is used to measure the size distribution of particles in colloidal solutions. It relies on the light scattering caused by the Brownian motion of particles in the liquid to determine their size.
Our Advantages
- Comprehensive particle analysis methods: Our company can use an array of particle analysis methods. This diversity of methods allows them to comprehensively analyze API particles, gaining insights into their characteristics from various angles.
- Wide size range analysis: Our company can analyze a wide variety of APIs with different particle sizes, accommodating the needs of various pharmaceutical formulations.
Delivery
| Particle shape | Particle size uniformity |
| Particle size deviation | Median particle size |
| Average particle size | Particle size distribution curve |
| Effects of environmental factors on API particles | Other experimental data |
Please kindly note that our services are for research use only.
