Water for Injection (WFI) Quality Water

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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. Sterile WFI is available in up to 1 L packages. 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.

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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
Sterility 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>