Water: The most-used raw material in your process

New: WFI Beyond - Water for Injection acc. to Ph. Eur. 0169 and beyond compendial | 500 mL & 1 L bottles in stock

Water goes into every buffer, every medium and every formulation - its quality sets the ceiling for everything built on it. “Meets WFI” only describes the floor.

With WFI Beyond we are expanding our water portfolio with Water for Injection according to Ph. Eur. monograph 0169 and beyond compendial. It is manufactured by PAN-Celltech GmbH in Aidenbach under EU-GMP guidelines (made in Germany) and is supported by a Drug Master File filed with the FDA.

WFI Beyond at a glance

• Endotoxin < 0.005 EU/mL - 50× lower than the Ph. Eur. limit (< 0.25 EU/mL)

• Conductivity < 0.2 µS/cm (Ph. Eur.: ≤ 1,1 µS/cm) and TOC < 0,05 mg/L (Ph. Eur.: ≤ 0,5 mg/L)

• Nase and DNase activity not detected

• All 24 elemental impurities per ICH Q3D(R2) tested by ICP-MS - specification set at 50% of the ICH Q3D parenteral limits

• FDA Drug Master File Type IV (excipient): MF044505

• 2-year shelf life from date of production at +15 °C to +25 °C (room temperature)

In stock: 500 mL and 1 L bottles

Our bottles are in stock and can be shipped at any time – usually within 24 hours. Every delivery includes the Certificate of Analysis (CoA) for the supplied lot.

Art.-No.	Product	Format	Availability
CT-981500	WFI Beyond	500 mL bottle	in stock, ready to ship at any time
CT-981000	WFI Beyond	1000 mL (1 L) bottle	in stock, ready to ship at any time

For research and development

Whether you prepare buffers and reaction mixes for mRNA and in-vitro transcription or run sensitive cell culture applications: with WFI Beyond, low endotoxin and absence of nuclease activity are not a matter of chance but part of the specification. The bottles are sterile, ready to use and documented lot by lot. And if your project grows towards GMP, you stay within one continuous water line - from Sterile Water for Cell Culture (P series) to WFI Beyond (CT series).

For biopharmaceutical applications

For buffer, media and formulation preparation in the manufacture of antibodies, mRNA/LNP products, cell and gene therapies and vaccines, WFI Beyond offers GMP manufacturing, lot-by-lot analytics including elemental impurities, and an FDA Type IV DMF that you can reference in your submission via a Letter of Authorization. In the next two e-mails we will show you the analytical data of a real production lot and what WFI Beyond means for your qualification and scale.

WFI Beyond is a raw material / excipient for further manufacturing (e.g. for compounding media and buffers and as a diluent) and is not intended for direct human use. The user is responsible for ensuring suitability for the intended use. All specifications and results refer to the Certificate of Analysis of lot 2560826 (Art. No. CT-981000, certificate dated 13 Oct 2026); lot-specific values may differ and are stated on the CoA supplied with each delivery.