TOC in the Japanese Pharmacopoeia

GMP News
20 June 2007

TOC in the Japanese Pharmacopoeia

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.

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

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