HYPER
PACKAGED PRODUCT ANALYSIS	METHOD OF REFERENCE	SPECIFICATION
Appearance	Visual	Clear & Colorless Liquid
Total Organic Carbon	USP <643>	< 8000 ppb
Conductivity	USP <645>	≤ 5 µS/cm
Endotoxin	USP <85>	≤ 0.05 EU/mL1
Sterility	USP <71>	No Growth
Particulate Matter	USP <788>	≥ 25 µm in size ≤ 3 particles/mL
		≥ 10 µm in size ≤ 25 particles/mL
Oxidizable Substances	EP Sterilized WFI	Solution remains faintly pink
Residue on Evaporation	EP Sterilized WFI	≤ 3 mg (0.003%)
Nitrates	EP Sterilized WFI	≤ 0.2 ppm

¹ The USP specification for Sterile Grade Water for Injection requires endotoxin levels to be less than 0.25 EU/mL. Aquabiliti applies a tightened specification, limiting endotoxin to less than 0.05 EU/mL.

WFI Generation Online Analysis		WFI-USP
Conductivity (µS/cm)	≤ 0.06 µS/cm	≤ 1.3 µS/cm
TOC	≤ 20 ppb	< 500 ppb