With regard to Sterile Water for Injection, the harmonisation between the
European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP) and the United
States Pharmacopoeia (USP) continues. It is proposed to delete all single
parameters in all three Pharmacopoeias and to keep only the requirements for
Conductivity, Oxidisable Substances (USP), Residue on evaporation (EP and
JP), Bacterial endotoxins, Particulate Contamination, TOC and Sterility with
For paragraph <645> Water Conductivity a comment will be
added, emphasising the advantage of using online measurement devices instead
of off-line testing. This comment derives from FDA and fits to the
authority's 20th century initiative. The same comment will be added to the
TOC paragraph <643>. No change to test limits are proposed.
For the informational chapter <1231> a passage for Pure
Steam has been added, giving more information with regard to definition,
usage and preparation of pure (or clean) steam for pharmaceutical use.
Moreover, a new monograph for 'Water for Pharmacy Use' is
under discussion within the USP.
Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)