Excipient analysis laboratory for the pharmaceutical industry
Your needs : to reliably analyze excipients found in your pharmaceutical products to meet regulatory requirements
Used in the pharmaceutical and cosmetics industries, an excipient is the name given to any substance present in a product that is not the active ingredient. While not having intrinsic therapeutic properties, excipients will give the final product new properties such as greater stability, better taste, a more desirable color, a different shape, etc.
To avoid any risks of chemical interactions or even toxic reactions, excipients are subject to stringent regulatory constraints especially as some of them can trigger allergies or intolerances (lactose, aspartame, formaldehyde, mannitol, wheat starch)
Pharmaceutical laboratories and excipient suppliers must verify that their excipients comply with relevant standards (detection of impurities) as well as evaluating their compatibility with the active ingredient, packaging and final use of the product. To achieve this, support from a laboratory specialized in analyzing active pharmaceutical ingredients will allow you to carry out regular inspections to ensure that your excipients stay in line with changing regulations.
Our solution : to provide you with the tools and experience needed to quickly and reliably evaluate your excipients
For over 30 years, FILAB has had the experience and specific analytical fleet needed to be able to assist pharmaceutical companies in analyzing their substances and excipients, all while providing tailored support.
From analysis to analytical development, FILAB can support your industrial projects while abiding by safety standards by providing the following services :
- Excipient characterization using GC-MS, LC-MS/MS, NMR…
- ICP-AES and ICP-MS screening and determination
- Particulate or contaminant analysis of excipients
- Detection of elemental impurities in excipients in accordance with the USP 233 (ICH Q3D)
- Compatibility testing between active ingredients and excipients
- Analytical development and validation of methods for determining excipient contents in accordance with relevant standards (ICH, USP, EP, ISO…)
- Reverse engineering of finished products
