Fully dedicated to Excipient Characterization

Excipients can have an important impact on the pharmaceutical and chemical performance of a drug product formulation. It’s therefore important to identify and control unknown Functionality Related Characteristics (FRCs) of excipient materials in order to achieve safe, robust and stable products.

Complementary to a Certificate of Analysis

Being active for 25 years in formulation development has learned us that the limited information on an excipient Certificate of Analysis often falls short in explaining observed formulation characteristics or in appointing product specific FRCs. So there must be more to it,....

In the past 15 years analytical scientists of Excipia have worked hard to set up unique analytical and physicochemical methods with ingenious sample preparation techniques and successfully filled this knowledge gap for a broad variety of excipients. For some excipients, up to one hundred unique batches of different grades and suppliers were analyzed to compile a knowledge database.

With all this, Excipia can help your company to identify critical FRCs of excipients and combination of excipients in a formulation, or investigate batch to batch variability, select specific excipient batches or set in-house specifications for customized product properties.

Reverse Engineering and Beyond

Our experience in excipient characterization enables us not only to identify and quantify individual excipients in a drug product (deformulation) but also to reveal and compare hidden excipient properties like the presence of potential reactive impurities or functional groups, degradation products and related substances, just like molecular weight distributions, degree of substitution, substituent distribution, monomer ratio and many other featured characteristics.

Hands-on troubleshooting services and solutions

Excipia offers fast and flexible hands-on solutions and troubleshooting services to pharmaceutical drug companies and excipient manufacturers that are encountering challenges such as:

• • • •
• Competitor research and analysis
• Deformulation or reverse engineering
• Selection of excipient or feedstock
• Batch-to-batch product performance variation, e.g. manufacturability, stability, release, etc.
• Identifying Functionality Related Characteristics (FRCs) and setting product specific (in-house) specifications
• Implementing a Quality by Design (QbD) approach
• Manufacturing process or site changes
• • • •