Excipient Reference Materials

Excipients are inactive ingredients formulated alongside an Active Pharmaceutical Ingredient (API) for purposes such as stability and therapeutic enhancement - including facilitating drug absorption or enhancing drug solubility.

Recent studies have demonstrated that excipients can also play a role in the introduction of potentially hazardous impurities - such as small molecule nitrosamines - into pharmaceutical products, meaning that they must be comprehensively risk assessed and carefully monitored throughout the drug development process.

A qualified, GMP/GDP compliant supplier with EXCiPACT certification, we offer more than 180 excipient reference materials manufactured according to ISO/IEC 17025 requirements, and an increasing number accredited to ISO 17034. Suitable for use with non-compendial analytical methods, each comes with a detailed Certificate of Analysis (CoA) describing its characterisation.