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. 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

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>

brochure

WFI Sell Sheet