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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 |
| 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> |
