Particle characterization of drug substances, drug products and excipients is an important topic in research and development (R&D), production and quality control. It is also becoming increasingly important for compliance with the requirements of the FDA and European health authorities.
Pharmacological behavior of a drug product can be influenced by a change in particle size or structure. In addition, information concerning potential contamination of injections and infusions is required as part of the safety assessment of the drug. Therefore, an intensive study of API and excipient particle size, from the drug development to manufacturing, can facilitate the development of safe, stable and efficient products.
We provide a wide range of services for particle testing to support research and development, and quality control, accelerating your products’ time-to-market.
Why choose particle analysis from SGS?
We can help you with the following:
- Particle size distribution analysis of solid state drug substances, drug products and excipients using sieving techniques (air-jet sieving and machine sieving)
- Particle size distribution from submicron to millimeter, wet or dry, from milligram to bulk quantities of pharmaceuticals using the Malvern laser diffraction technique
- Visible and sub-visible particle contamination testing
- Optical microscopy/scanning electron microscopy (size, shape and elemental analysis)
- Characterization by using Thermogravimetric Analysis (TGA)
- Grain size analysis
- Cleanliness: e.g. proof of parts cleaning efficiency by X-ray photo electron spectroscopy (XPS)
- X-ray diffraction (XRD)
World-leading particle analysis from a trusted provider
As world leader in testing, inspection, verification and certification, we offer you extensive experience in particle analysis, delivering an accurate and cost-effective service to help you develop a safe and reliable biopharmaceutical product.
One of the most critical parameters for excipients and active substances are the particle properties, especially particle size. Particle size is potentially critical for:
- Dissolution
- Bioavailability
- Solubility
- Stability
- Processability
- Appearance
- Safety
Our range of particle analytical technologies includes:
- Malvern Mastersizer 2000/3000
- Malvern Zetasizer
- Retsch AS200
- Alpine AITR-JET 200LS-N
- HIAC Royco 9703
- Environmental Scanning
- Electron Microscope
- TGA Mettler Toledo TGA11100
To discuss your particle analysis requirements, contact us today.