The revision – which was adopted at a meeting in Strasbourg, France this month – allows processes like reverse osmosis (RO) and other non-distillation techniques to be used to purify water for injection (WFI) in addition to distillation, which was previously the only approved method.
The debate about whether alternative methods should be allowed began in the late 1990s when a proposal to allow RO was rejected due to a lack of evidence of efficacy.
In 2010 the European Directorate for the Quality of Medicines & HealthCare (EDQM) set out to see if more supportive data was available. The research revealed that firms using such membrane-based technologies were consistently able to meet puristy specifications detailed in the monograph.
However, the finding did not prompt a revision because – as the EDQM noted at the time – most firms using RO also used UF and ultraviolet or ozone treatments. In addition, most had access to high-quality feed water.
In the years since membrane-based purification technologies have advanced.
In April last year the EDQM proposed the revision again, telling us at the time that manufacturers it consulted had backed the use of non-distillation methods citing lower cost and improved sustainability.
The newly accepted monograph revision also brings the European Pharmacopoeia more closely into line with monographs in the US and Japan.
The revised monograph for Water for Injections (0169) will be published in the Ph. Eur. Supplement 9.1 and will become effective in April 2017.