Harmonisation of Pharmaceutical Water Requirements in Pharmacopoeias Continues

 
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 harmonised specifications.

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.

Prepared by:
Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)