Quality of water for pharmaceutical use

This guideline applies to human and veterinary medicines.

July 2020 update: The guideline has been updated to reflect changes in the European Pharmacopoeia including the revised monograph for Water for Injections allowing methods other than distillation for producing water of injectable quality. The guideline has also been updated to reflect current expectations for the minimum acceptable quality of water used in the manufacture of active substances and medicinal products for human and veterinary use. The updated guideline will be effective from 1 February 2021.

Keywords: Water, pharmaceutical use, grade, excipient, water for injections, purified water, distillation, reconstitution

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