Water for Injection (WFI)

WFI stands for “Water for Injection” and is a special type of water used in the pharmaceutical industry for the production of injectable solutions, parenteral drugs, and other sterile products.

WFI must meet strict quality standards and comply with the requirements of the relevant pharmacopoeias or regulatory guidelines to be considered safe and suitable for human use.

WFI is frequently used as the starting material for the production of parenteral drugs, including injectable solutions, infusion solutions, powders for injections, and other sterile products.

Some key characteristics of WFI include:

• High purity, sterility, and low endotoxin levels.
• Compliance with regulatory requirements: The production of WFI is subject to strict regulatory requirements and standards set by the relevant pharmacopoeias (such as the European Pharmacopoeia, the United States Pharmacopeia) or other regulatory guidelines. WFI manufacturers must ensure that their production facilities and processes comply with the applicable regulations and are regularly reviewed and validated.