Comprehensive Guide to Water for Injection (WFI) Specifications in Pharmaceuticals
Water for Injection (WFI) is one of the most critical utilities in the pharmaceutical industry. It is a highly purified form of water used for the production of parenteral (injectable) products, cleaning of equipment, and preparation of sterile formulations. WFI must meet stringent pharmacopoeial specifications to ensure that it is free from contaminants, pyrogens, and microorganisms that could compromise product safety or patient health. 1. Introduction to Water for Injection (WFI) In pharmaceutical manufacturing, water serves as a key raw material, ingredient, and cleaning agent. The quality of water used directly impacts product purity, safety, and efficacy. Among different grades of pharmaceutical water — such as Purified Water (PW) , Water for Injection (WFI) , and Sterile Water for Injection — WFI is the purest and is strictly regulated by international pharmacopoeias such as USP, EP, BP, JP, and IP . WFI is specifically used in: Preparation of sterile dosage forms (...