[Note—For microbiological guidance, see Water for Pharmaceutical Purposes <1231>.]
Purified Water is water obtained by a suitable process. It is prepared from water complying with the U. S. Environmental Protection Agency National Primary Drinking Water Regulations or with the drinking water regulations of the European Union or of Japan, or with the World Health Organization's Guidelines for Drinking Water Quality. It contains no added substance.
[Note—Purified Water, whether it is available in bulk or packaged forms, is intended for use as an ingredient of official preparations and in tests and assays unless otherwise specified (...