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Water for Injection (WFI) Quality Water
High-purity water used for the preparation of cell culture media, buffers, and aqueous reagents.
ILC Dover’s WFI Quality Water is produced in a cGMP-compliant, US-based facility and meets monographs for pharmacopoeias around the world, including US Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). WFI Quality Water can be provided in standard and custom packaging up to 200 L or filled directly into specified packaging. Through a distillation still combined with upstream purification and 0.1 μm filtration, intrinsically safe WFI is created with significantly less risk than other production methods.
Applications
- Preparing Cell Culture & Buffers
- Reconstituting Dry Reagents
- Manufacturing High-Purity Aqueous Reagents
- Rinsing Critical Equipment
Why WFI from ILC Dover?
Global Compliance
Tested for USP, Ph. Eur., and JP monographs with a Certificate of Analysis (CoA).
Air Cleanliness
Suitable for ISO 7 cleanroom classifications.
Comprehensive Testing
On-site analytical and microbiology testing.
Intrinsically Safe
Processed through distillation still, upstream purification, and 0.1 μm filtration.
WFI by the Specs
Scroll to explore assay, specification, and method details.
Assay
Specification
Method
Pass
USP<71>, 21CFR610, EP (2.6.1), JP<4.06>
Endotoxin
<0.25 EU/mL
USP<85>, EP (2.6.14), JP<4.01>
Conductivity
≤ 5 μS/cm
USP<645>, EP Sterilized WFI, JP<2.51>
Oxidizable Substances
Conforms
USP/EP Sterile WFI
TOC
≤ 8000 ppb
USP<643>
Acidity or Alkalinity
Conforms
EP Sterilized WFI
Chlorides
Conforms
EP (2.4.4)
Nitrates
NMT 0.2 ppm
EP Sterilized WFI
Sulfates
Conforms
EP Sterilized WFI
Ammonium
NMT 0.2 ppm
EP Sterilized WFI
Calcium and Magnesium
Conforms
EP Sterilized WFI
Heavy Metals
NMT 0.1 ppm
EP (2.4.27)
Particulate Matter
Conforms
USP<788>, EP (2.9.19), JP<6.07>
Residue on Evaporation
NMT 0.003%
EP Sterilized WFI
Purity
Conforms
JP Sterile WFI in Containers
Extractable Volume
Conforms
JP<6.05>
Foreign Insoluble Matter
Conforms
JP<6.05>
