HYPER (USP/EP) Water for Injection

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Aquabiliti’s HYPER Water For Injection (WFI) is available in multi-compendial USP/EP grades for WFI quality water and packaged in bulk for commercial use. Our WFI quality water meets the needs of upstream and downstream bioprocessing and manufacturing applications and complies with the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) as indicated.

Aquabiliti’s HYPER Water For Injection (WFI) is available in multi-compendial USP/EP grades for WFI quality water and packaged in bulk for commercial use. Our WFI quality water meets the needs of upstream and downstream bioprocessing and manufacturing applications and complies with the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) as indicated.

Available in a wide range of packaging and testing options to support your research, development, or manufacturing workflows.


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Specifications


AQUAPure Logo 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 AQUAPure Logo WFI-USP
Conductivity (µS/cm) ≤ 0.06 µS/cm ≤ 1.3 µS/cm
TOC ≤ 20 ppb < 500 ppb


Compliance Information