Excipia Experts in excipient analysis, characterization and deformulation / reverse engineering

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Excipients can have an important impact on the manufacturability and pharmaceutical performance of a formulation. It’s therefore important to identify and control functionality related characteristics (FRCs) of excipient materials in order to achieve safe, robust and stable products. Experience has taught us that the limited information on an excipient Certificate of Analysis is in many cases not useful in explaining observed formulation properties or in finding product specific FRCs. Excipia has therefore spent thousands of hours setting up a unique set of complementary physicochemical methods and ingenious sample preparation techniques covering many different excipients. For some excipients, we have been analyzing up to one hundred unique batches of different suppliers to fill our knowledge database. Our experience in excipient characterization enable 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, but also molecular weight distributions, degree of substitution, substituent distribution, monomer ratio and many other featured characteristics. Excipia offers fast and flexible hands-on solutions and troubleshooting services to excipient manufacturers and pharmaceutical drug companies that are encountering challenges such as: • Competitor research and analysis • Selection or change of supplier of excipient or starting material • Batch to batch product performance variation, e.g. manufacturability, stability, release, etc. • Identifying functionality related characteristics and setting product specific (in house) specifications • Implementing a Quality by Design approach • Manufacturing process or site changes • Deformulation/Reverse Engineering Feel free to get in touch with our experts to see how we can help you in making your products safe, robust and stable. Be in control of your product! www.Excipia.eu
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Excipia Experts in excipient analysis, characterization and deformulation / reverse engineering

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