Particle testing is vital to ensure the quality and effectiveness of medicinal products.
The number and size of particles have a direct impact on the performance of pharmaceuticals and medical devices.
In solid dose or emulsion based medicines, the particle size distribution and number of particles can directly affect the efficacy of the product. Particle shape characterization is indispensable for flowability of powder, milling efficiency, dissolution of Active Pharmaceutical Ingredients (API), and rate of reaction.
Within implantable medical devices and injectables, the particulate is unwanted and can impact the patient’s health if present in large numbers and large sizes.
Exova’s team of experienced scientists can perform particle testing and analysis following USP, EP, ASTM and ISO methods. Our particle characterization techniques include:
- Particle Size Distribution (PSD) by light scattering
- Particle counting by light obscuration
- Scanning Electron Microscopy (SEM)
- Light Microscopy (LM)
- Microscopic image analysis
Exova provides extensive experience in particle characterization. We can develop and optimize characterization methods specific to your product, as well as support you with method transfer and validations. Our scientists are adept at helping you to meet the appropriate quality and regulatory standards.
As a Good Manufacturing Practice (cGMP) compliant laboratory, we recognize the importance of putting product quality first and maintaining production excellence at each and every step in the pharmaceutical manufacturing process.
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1300 First State Blvd, Suite C,
Wilmington, DE 19804
Contact: Waheed Sheikh - President
Tel: +1 302-636-0202
Fax: +1 302-636-0204