IPEC e-newsletter - Excipients Insight June 2014 - 30-06-14

 

Inside this issue

     

IPECs provide comments on Chinese Pharmacopeia

IPEC Europe and IPEC Americas have provided feedback to the Chinese Pharmacopeia (ChP) - via IPEC China -  on various elements of the ongoing revision of excipient monographs for the forthcoming 2015 edition.

ChP has said it intends to dramatically increase the number of excipients included in the 2015 revision to more than 380 from just 132 in the 2010 edition. The IPECs are trying to ensure the new version is as harmonised as possible with the pharmacopeias of the US, Europe and Japan, to avoid out-of-specification (OOS) problems for imported excipients.

IPEC Europe's Pharmacopoeial Review and Harmonization (PR&H) Committee and IPEC America's Compendial Review Committee (CRC) have forwarded comments on: Appendix II A - Pharmaceutical Excipients; Appendix XIX R - Pharmaceuticals Excipients Functionality-Related Characteristics (FRCs); and Appendix VI G - Viscosity, as well as the proposed monographs for: Maltodextrin; PEG 300 and PEG 400; Poloxamer 118 for injection; and Polyoxyethylene 35 castor oil for injection.

There were no comments from the IPEC membership on two other monographs among the first batch proposed by ChP, namely Polysorbate 80 for injection and Propylene Glycol for injection.

The 2015 edition of the ChP is scheduled for completion by the end of the year.

 

 

 

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