The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Composition Guide for Pharmaceutical Excipients


IPEC Europe, Avenue des Gaulois, 9; 1040 Brussels

Document Type:
IPEC Industry Best Practice document
This document offers best practice and guidance in the consideration of an excipient composition profile. The excipient supplier may be a manufacturer or a distributor (or both). The Guide highlights the factors to consider when assessing an excipient composition profile, particularly in the context of Design Space and Quality by Design.

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