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.
We can help you with the following:
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:
Our range of particle analytical technologies includes:
To discuss your particle analysis requirements, contact us today.
2nd Floor Alegria Office Building. 2229 Chino Roces Avenue,
1223,
Makati, Metro Manila, Philippines