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The changes in the 15th revision of the Japanese Pharmacopoeia (JP), which
became effective in April 2006, are mostly unknown in Europe and the US. The
reason may be that there is still no official translation, which is expected
in the next few months.
For the first time there is a requirement on TOC monitoring of water for
injection in the new revision. As far as content is concerned, the JP is
very similar to the USP. However, with regard to the specifications, the JP
goes one step ahead. Besides the specification limit of 500 ppb, which is
identical with the USP und Ph.Eur. requirements, the Japanese Pharmacopoeia
establishes an action limit of less than 400 ppb for offline measurements
and less than 300 ppb for online measurements. With regard to equipment
requirements the JP is also more detailed. A thorough selection is requested
taking into consideration the appropriateness of the TOC measuring device
for the feed water used. It has to be shown that potentially present
substances, like nitrogen-, sulphur- and halogen-containing organic
compounds, do not alter the measurement result. Devices complying with the
system suitability test according to USP <642> and Ph.Eur. 2.2.44 are
explicitly accepted though.
Author:
Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)
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