WFI Beyond
Water for Injection, Beyond Compendial
Water for Injection engineered beyond the Ph. Eur./USP monograph · GMP (EU Annex 1) · backed by FDA DMF MF044505
WFI Beyond is a beyond-compendial grade of Water for Injection, controlled past the Ph. Eur./USP monograph and backed by FDA Drug Master File MF044505. WFI Beyond is purified and controlled to exceed the Ph. Eur./USP Water-for-Injection monograph on the attributes that decide an advanced biologic. The monograph is rooted in 1969, written for the medicine of that era; WFI Beyond is built for the medicine of today and tomorrow — and backed by a filed FDA Drug Master File (MF044505) you can reference in your own submission.
Why WFI Beyond
- Ultra-low endotoxin — < 0.005 EU/mL — more than 50× below the monograph limit.
- Very low organic carbon — < 0.15 mg/L — more than 3× below the limit.
- Exceptional conductivity — < 0.2 µS/cm — more than 5× below the limit.
- Nuclease- & nitrosamine-free — RNase & DNase not detected; no nitrosamines.
- A first: full elemental profile — all 24 ICH Q3D elemental impurities quantified on every CoA.
- Sterility twice over — 0.1 µm filtration plus gamma irradiation to SAL 10⁻⁶.
Specifications at a glance
| Property | Detail |
|---|---|
| Endotoxin | < 0.005 EU/mL (Ph. Eur. 2.6.14) |
| Total organic carbon | < 0.15 mg/L (routinely) |
| Conductivity | < 0.2 µS/cm (20 °C) |
| Nuclease activity | RNase & DNase not detected |
| Elemental impurities | 24 elements, ICP-MS, to ICH Q3D — values on every CoA |
| Sterility | Sterile-filtered 0.1 µm; gamma-irradiated to SAL 10⁻⁶ |
| Basis | Water for Injection, Ph. Eur. 0169 and beyond compendial · GMP (EU Annex 1) |
| Regulatory | FDA Type IV DMF · MF044505 |
Manufactured by PAN-Celltech GmbH, Aidenbach, Germany. Single-use, gamma-irradiated from production to delivery.
Ordering & grades
| Grade | Catalogue no. | Size | Use |
|---|---|---|---|
| GMP | CT-981500 | 500 ml bottle | GMP / beyond compendial |
| GMP | CT-981000 | 1000 ml bottle | GMP / beyond compendial |
| GMP | CT-98001B … CT-981000B | 1 L – 1000 L bags | GMP / beyond compendial |
Request spec, CoA or DMF letter of authorizationTalk to our water team
Applications
- Monoclonal antibody manufacturing — low elemental impurities, ultra-low endotoxin
- mRNA & LNP — nuclease-free water protecting the payload
- Cell & gene therapy — ultra-low endotoxin, nuclease-free, sterile
- Vaccine production — endotoxin control and sterility at scale
- Recombinant proteins — low endotoxin and organic carbon
Key terms
| Term | Meaning |
|---|---|
| WFI | Water for Injection — the pharmacopoeial grade of water permitted in injectable medicines (Ph. Eur. monograph 0169). |
| Endotoxin | Pyrogenic fragments of bacterial cell walls; the Ph. Eur. WFI limit is < 0.25 EU/mL. |
| TOC | Total organic carbon — a measure of organic purity; the WFI monograph limit is 0.5 mg/L. |
| Nuclease-free | No detectable RNase or DNase activity — protects RNA/DNA and mRNA payloads. |
| ICH Q3D | The international guideline that sets safe limits for 24 elemental (metal) impurities in medicines. |
| SAL 10⁻⁶ | Sterility Assurance Level of one-in-a-million — the pharmaceutical standard for terminal sterilisation. |
| DMF | Drug Master File — confidential data filed with the FDA that a customer references in their own submission via a letter of authorization. |
| GMP (EU Annex 1) | Good Manufacturing Practice for the manufacture of sterile medicinal products in the EU. |
Frequently asked questions
What makes WFI Beyond “beyond compendial”?
It is controlled to exceed the Ph. Eur./USP WFI monograph on endotoxin (more than 50× below the limit), total organic carbon (more than 3× below), conductivity (more than 5× below) and nuclease activity, and adds elemental-impurity control the monograph does not require.
Is WFI Beyond backed by a Drug Master File?
Yes — a filed FDA Type IV Drug Master File, MF044505. You can reference our confidential manufacturing and quality data in your own submission through a simple letter of authorization.
Is it nuclease-free and nitrosamine-free?
Yes. RNase and DNase are not detected, protecting mRNA and nucleic-acid payloads, and it is free of nitrosamines.
How is sterility assured?
Twice over: the bulk is sterile-filtered to 0.1 µm — tighter than the usual 0.2 µm — and the single-use containers are gamma-irradiated to a Sterility Assurance Level of 10⁻⁶.
What sizes are available?
Bottles of 500 ml and 1000 ml, and single-use bags from 1 L to 1000 L (CT-98 series).
Related: Technical paper: Beyond Compendial · WFI Quality Water · Sterile Water for Cell Culture · Water Solutions