Water for Injection (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer.
- BioProcess Applications- Cell Culture Media & Purification Buffers
- Pharmaceutical Manufacturing
- Medical Device Processing and Testing
- Manufactured under cGMP and ISO 13485 guidelines in a FDA registered facility.
- Complies with the United States Pharmacopoeia (USP) monograph for water for injection packaged in bulk for commercial use elsewhere.
- Nitrosamine Impurity Free
- Multiple packaging sizes available, including 200L, 100L, 20L, 10L, 1L and 500mL.
Our Terminally Distilled Water for Injection (WFI) is is a sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. It complies with both United States Pharmacopoeia (USP) testing monograph for water for injection packaged in bulk for commercial use elsewhere.
Water for Injection specific product test requirements and typical values are given below:
| Parameter | Method | Specification |
|---|---|---|
| Appearance | Visual | Clear and Colorless Liquid |
| Conductivity (packaged) | USP <645> | <5.0 µS/cm |
| Endotoxin | <0.25 EU/mL | |
| Oxidizable Substances | USP | Solution Remains Faintly pink |
| Particulate Matter | USP <788> | Meets USP Particle Requirements |
| pH | USP <791> | 5.0-7.0 |
| Sterility | USP <71> | No growth |
| TOC (before packaging) | USP <643> | <500 ppb |
