Although water for injection is not required to be sterile, it must be pyrogen free. True False

The statement is False.

Water for injection (WFI) must indeed be both sterile and pyrogen-free. Sterility is essential because WFI is used in the preparation of sterile products, such as injectable drugs. Even though WFI is primarily intended for the preparation of drug solutions, the absence of pyrogens—substances that can cause fever in patients—also plays a critical role. Pyrogens are typically produced by bacteria and can trigger harmful immune responses.

Regulatory bodies, such as the United States Pharmacopeia (USP), set standards that require WFI to be prepared in a manner that ensures both its sterility and safety for patient use. Therefore, the correct understanding of WFI's requirements highlights its importance in maintaining product integrity and patient safety during pharmaceutical preparation.