1231 Water for Pharmaceutical Purposes , USP 34 page 787. A number of changes are proposed for this general information chapter related to packaged waters and how leachable organics from the packaging components render the waters sometimes significantly less pure than their namesakes. In the case of packaged forms of bulk Purified Water and Water for Injection, the proposed changes relate to microbial control of these nonsterile waters and leachables from their packaging that may render them unsuitable for certain uses. Additional discussion of packaging leachables has been added to the section on Sterile Water for Injection, as well as to the Chemical Considerations section regarding how the original organic purity test, Oxidizable substances, facilitated the presence of organic packaging leachables, particularly in the sterilized waters. Additional changes are proposed to the discussion of Pure Steam to clarify the lack of need for microbial testing, and to the discussion of Filtered Water and High-Purity Water to correct inaccuracies.
(GCCA: A. Hernandez-Cardoso.)
Comment deadline: July 31, 2011
Attachment: EU GMP Annex 11 Rev2011