Water for pharmaceutical use: Importance, types and quality requirements

Abstract

Owing to its safety, wide distribution, and unique physicochemical properties, water is indispensable in pharmaceutical industry as excipient, solvent for extraction, production of active ingredients and analytical reagents, cleaning and heat-transfer agent. Various water types are used for production of pharmaceutical preparations and the water quality requirements depend on characteristics and use of final pharmaceutical preparation and production stage at which is water used. This paper summarizes regulatory requirements related to water for pharmaceutical use and systems for water production, storage and distribution in pharmaceutical industry, with focus on current regulation changes in this field. An overview on types of water for pharmaceutical use is provided, especially that official in the European and the United States Pharmacopoeia, including their quality requirements, usage and production methods.

Keywords

• purified water
• water for injections
• water quality
• water purification systems