The European Pharmacopeia (Ph. Eur.) has released for comment a draft chapter on co-processed excipients. A co-processed excipient is defined as any combination of two or more excipients obtained by physical co-processing that does not lead to the formation of covalent bonds. It notes that the individual components of a co-processed excipient must comply with the requirements of any corresponding individual monographs and of the general monograph on substances for pharmaceutical use. Sections are included on: ● production ● characteristics ● identification ● pharmacopeial tests ● labeling, and ● functionality-related characteristics. Comments are due by December 31, 2015. The draft can be viewed here after logging into the EDQM site.
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