EDQM publishes updated Ph.Eur. Water Monographs for comment

The EDQM has revised the monographs Water for injection 0169 (WFI), Purified water 0008 (PW) and TOC Level in Pharmaceutical Water (2.2.44) and has now published them for comment.

The changes in the three monographs are not very dramatic and are mostly of an editorial nature. Worth mentioning are:

Water for injection (0169)

The limit value for TOC (2.2.44 Method A) was restricted from max. 0.5 mg/L to max. 0.50 mg/L.

For "Sterilized water for injection", the test for oxidizable substances is omitted. TOC method B is required. For the test "Residue on evaporation", the (unchanged) limit value has been changed from percentage to ppm. An adjustment to SI units (mg/mL) would have been more comprehensible.

Purified Water (0008)

The change to 0.50 mg/L for the TOC test was also adopted for purified water.

For "Purified water in containers", the test "Residue on evaporation" was also changed from percent to ppm.

Total organic carbon in water for pharmaceutical use (2.2.44)

In the description of the TOC water to be used in method A, "highly purified water" has been replaced by "water", which corresponds to the specifications (LF <= 1.0 µS/cm at 25 °C and TOC <= 0.1 mg/L).

The monographs can be found in draft status on the website of the European Pharmacopoeia. Access is free of charge, but requires a one-time, free registration. Comments are possible until September 30, 2024.