Friday 19 May 2017

European Pharmacopoeia 9th Edition (Supplement 9.1)

The 1st supplement to the 9th edition of the European Pharmacopeia became effective on 1st April 2017.

Of interest to readers:

Water for injections (0169)

Production: revision to include purification processes equivalent to distillation (such as reverse osmosis coupled with appropriate techniques) for producing water for injections (WFI), in addition to distillation; use of non-distillation technologies for the production of WFI requires that notice is given to the supervisory authority of the manufacturer before implementation.

A requirement for regular monitoring of total organic carbon has been added to further emphasize the specific test controls required in the Production section.

Posted by Dr. Tim Sandle

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