WFI Beyond, Water for Injection, acc. to EP monograph 0169 and beyond compendial
€49.80
Product information "WFI Beyond, Water for Injection, acc. to EP monograph 0169 and beyond compendial"
WFI Beyond is a beyond-compendial grade of Water for Injection, controlled past the Ph. Eur./USP monograph and backed by a filed FDA Drug Master File (MF044505).
WFI Beyond exceeds the Ph. Eur./USP Water-for-Injection monograph precisely on the attributes that decide suitability for modern biologics: endotoxin level, organic carbon, conductivity and no nuclease activity. This is complemented by a full ICH Q3D elemental-impurity profile on every CoA and a nitrosamine risk assessment to current EMA guidance.
These features make WFI Beyond particularly suitable for demanding applications in mRNA technology, cell and gene therapy, and antibody and vaccine production.
Typical Applications
- Monoclonal antibody production
- mRNA and LNP formulations
- Cell and gene therapy
- Vaccine production
- Recombinant protein manufacturing
Product Features
- Endotoxin < 0.005 EU/mL – more than 50× below the monograph limit
- TOC < 0.05 mg/L – more than 10× below the limit
- Nuclease-free (RNase/DNase not detected)
- Full ICH Q3D elemental-impurity profile
- Sterile: 0.1 µm filtered, aseptically filled (Grade A), gamma-irradiated (SAL 10⁻⁶)
- Backed by FDA Drug Master File MF044505
| Quality: | GMP Excipient RNase - Free |
|---|---|
| Size: | 500 ml |
| Storage: | RT |