Pharmaceuticals

Production of EP Water for Injection— A Technical Overview

By William V. Collentro

BACTERIA CHLORAMINES DISTILLATION EDI ENDOTOXINS EP ION EXCHANGE PHARMACEUTICALS PHARMACOPEIAS PRETREATMENT REVERSE OSMOSIS STAINLESS STEEL STANDARDS ULTRAFILTRATION USP WFI

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Abstract

Alternate methods of producing Water for Injection (WFI) by reverse osmosis (RO) have been accepted by the United States Pharmacopeia (USP) for more than 30 years. The current edition of USP states that “Water for Injection is water purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms.” However, the current edition of the European Pharmacopeia (EP) states that “Water for Injection in bulk is obtained from water that complies with the regulations on water intended for human consumption laid down by the compliant authority or from Purified Water by distillation in an apparatus of which the parts in contact with the water are of neutral glass, quartz, or suitable metal and which is fitted with an effective device to prevent entrainment of droplets.

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