WFI Quality Water

Accelerate your Biologics Manufacturing with a high-quality solution that meets stringent USP and/or EP standards

Water for Inyection (WFI) Quality Water, Animal-derived component-free, meets the most stringent USP and/or EP compendial grade specifications. Manufactured in a ISO 13485:2016 and GMP-certified facility, located in Boecillo, Valladolid (Spain), following GMP compliant procedures to ensure the highest quality standards. It provides you the confidence to achieve exceptional results, with unparalleled purity and reliability with a secure supply chain.


For a Custom Packaging or OEM solutions, please Contact us.

Price: 25.60 1,396.00 

SKU: E0335 Categories: ,

Detailed information:

Advantages & Features
  • Reliability beyond Measure: manufactured in our ISO 13485:2016 and GMP-certified facility, meeting the USP/EP specifications.
  • Versatility Empowered: caters to a wide range of applications inside Pharmaceutical Manufacturing and Research.
  • Unmatched Purity: due additional steps to eliminate impurities, offering low levels of endotoxins, conductivity, and microbial contaminants.
  • Quality Guaranteed: including CoA for each lot of products manufactured.
  • Supply Chain Guaranteed: due our strategic location, and deep expertise managing regulatory agencies and shipping globally.
  • Increase process Efficiency and Reduce Costs: improve efficiency and reduce QC testing with larger batch volumes, reduce cycle times with just-in-time solutions and capacity constraints.
  • Highly experienced Regulatory and Technical expertise: that eliminate raw material risks and batch-to-batch inconsistencies.
Test  Specification /Units Method references
Appearance clear and colourless liquid Ph. Eur. 2.2.1; 2.2.2 and 2.9.20.
Nitrates maximum 0.2 ppm According to Ph. Eur
Aluminium maximum 10 ppb Ph. Eur. 2.4.17
Heavy metals maximum 0.1 ppm Ph. Eur. 2.4.8
pH 5.0 – 7.0 Ph Eur 2.2.3
Conductivity maximum 5 µS·cm Ph. Eur. 2.2.38.
Bacterial endotoxins maximum 0.25 EU/mL Ph. Eur. 2.6.14
Oxidisable substances Not Detected According to Ph. Eur
Total Organic Carbon maximum 0.5 mg/l Ph. Eur. 2.2.44
Ammonium maximum 0.2 ppm According to Ph. Eur
Chlorides maximum 0.5 ppm Ph. Eur. 2.4.4
Bioburden maximum 0.1 CFU/mL Ph. Eur. 2.6.12

Includes for 1L:

-1,000 mL of WFI Quality Water served in PET Bottle.


Includes for 20L:

-20L of WFI Quality Water served in Single-use container.


Includes for 200L:

-200L of WFI Quality Water served in Single-use container with Plastic Drum


To know more about our Packaging or request a different one, please Contact us.

Download documentation

WFI Quality Water, is a versatile solution designed for a wide range of Further Manufacturing and Research applications:


  • Buffer Preparation: Achieve reliable results in rinse, purification, and chromatography processes. It provides the essential foundation for preparing buffers, ensuring accurate and efficient sample separation and purification.
  • Cell Culture Hydration: Experience optimal cell culture performance by using for the hydration of cell culture media, supplements, and salt solutions. It provides the necessary purity to support healthy cell growth and accurate experimental results.
  • Synthesis Reconstitution and Rehydration: perfect choice for reconstituting and rehydrating products during synthesis. Its exceptional purity and reliability make it an ideal solvent, allowing for precise and consistent results.
  • Thorough Rinsing: Ensure the utmost cleanliness and sterility of primary packaging,production vessels, equipment, and room surfaces. Its high-quality guarantees effective rinsing and helps maintain the integrity of your processes.
Tables & Figures

Quality Control

WFI Quality Water is manufactured in an ISO 13485:2016 and GMP-certified facility, located in Boecillo, Valladolid (Spain), following GMP compliant procedures to ensure the highest quality standards. Our processes include:

    • Batch-to-batch consistency.
    • Facilities audited regularly Quality audits.
    • Lot specific CoAs and QA review previously to release a product.
    • Material traceability, documented procedures and documented employee training.
    • Equipment maintenance and monitoring records.

Canvax GMP Buffers are manufactured and tested in accordance with Ph. Eur. 5.2.12 for “Raw materials of biological origin for the production of cell-based and gene therapy medicinal products” and USP <1043> on ancillary materials.


At Canvax, we are at the forefront of reagents manufacturing for RUO, IVD or Clinical Grade, driven by a passion for Excellence. With 20+ years of industry expertise and a commitment to innovation, we deliver superior Buffers & Liquid Solutions up to GMP Grade, for your critical manufacturing applications.

Storage, Shipping & Guarantee
  • Shipment at Ambient Temperature.
  • Storage: Room Temperature.
  • Shelf life: 24 months from data of manufacturing, based on our Accelerated Stability Testing Program, with both Normal and Accelerated
    Stability Testing Programs ongoing.
Safety Statements

This product is developed, designed and sold exclusively for Research purposes and in vitro use only (RUO) and Further Manufacturing. The product was not tested for use in diagnostics, drug development, terapeutic use, nor is it suitable for administration to humans or animals. For more info, please check its Material Safety Data Sheet available in this website or Contact us.

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