According to the United States Pharmacopeia (USP), Water for Injection (WFI) must comply with stringent purity parameters, most notably a Total Organic Carbon (TOC) limit of not more than 500 parts per billion (ppb) and a Stage 1 electrical conductivity limit of less than 1.3 microSiemens per centimeter (μS/cm) at 25 degrees Celsius. Additionally, for microbial and biological safety, WFI must contain fewer than 0.25 Bacterial Endotoxins Units per milliliter (EU/ml) and maintain strict total aerobic microbial counts well below standard purified water limits to ensure absolute sterility for clinical use.
1 votes
Marked as accepted