Our terminally distilled Water for Injection, EP/USP, is a 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
- Nitrosamine Impurity Free
Our terminally distilled Water for Injection (WFI), multi-compendial United States Pharmacopeia (USP) / European Pharmacopeia (EP) grade, is a sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer.
Sterile Water For Injection specific product test requirements and typical values are given below:
| Parameter | Method | Specification |
|---|---|---|
| Acidity-Alkalinity | EP | Conforms |
| Ammonium | EP | <=0.2 ppm |
| Appearance | Visual | Clear and Colorless Liquid |
| Calcium and Magnesium | EP | A Blue Color is Produced |
| Chlorides | EP | No Change in Appearance |
| Conductivity (packaged) | USP/EP | <=5.0 µS/cm |
| Endotoxin | USP/EP | <0.25 EU/mL |
| Nitrates | EP | <=0.2 ppm |
| Oxidizable Substances | USP/EP | Solution Remains Faintly pink |
| Particulate Matter | USP/EP | Meets USP/EP Requirements |
| pH | USP/EP | 5.0-7.0 |
| Residue on Evaporation | EP | <=3.0 mg (0.003%) |
| Sterility | EP | No growth |
| Sulfates | EP | No Change in Appearance |
| TOC (before packaging) | USP/EP | <= 0.5 mg/L |
