补充描述:
Excipients can significantly affect a formulation's manufacturability and pharmaceutical performance, making it important to identify and control their functionality-related characteristics (FRCs) to achieve safe, robust, stable products. Because the limited information on a typical excipient certificate of analysis often fails to explain observed formulation behavior or reveal product-specific FRCs, Excipia has invested thousands of hours developing a unique, complementary set of physicochemical methods and inventive sample preparation techniques spanning many excipients, in some cases analyzing up to a hundred unique batches from different suppliers to build its knowledge database. This depth of experience in excipient characterization enables the company to identify and quantify individual excipients within a drug product.
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