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USP Compliant

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Sterile

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cGMP Facility

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Made in USA

Overview

Kodak Water for Injection (WFI) is produced in a U.S. based, cGMP facility using a multi-step purification process that includes reverse osmosis, continuous deionization, UV disinfection, and distillation. Every lot is produced in compliance with the United States Pharmacopoeia (USP) standard.

Common uses

  • Bioprocessing
  • Buffer/media preparation
  • Washing and rinsing

Not intended for

  • Diagnostic or therapeutic use
  • Human administration
  • Tissue culture media for human ex vivo tissue and cell culture applications

Formulations

Water for Injection (WFI) Water for Injection (WFI), RNase/DNase/Protease Free

• Endotoxin: < 0.25 EU/mL
• Water Type: USP Water for Injection (no additives)
• Class: Class 1 Medical Device

• Endotoxin: < 0.25 EU/mL
• Water Type: USP Water for Injection (no additives)
• Class: Class 1 Medical Device
• RNase/DNase/Protease – none detected





Specifications (summary)

Attribute Specification
Appearance Clear/Colorless Liquid
Conductivity < 5µS/cm
Total Organic Carbon ≤ 500 ppb at filling
Endotoxin < 0.25 EU/mL
pH Distribution 5–7
Sterility No growth
Operating Conditions 15–38 °C
Storage Conditions 15–30 °C (ambient)
Shelf Life Shown on label
Packaging 1-liter sterile PETE bottles (recyclable)
Bottled and sealed in an aseptically controlled, cGMP environment
Manufacturing Origin Rochester, NY, USA

Key differences by formulation

WFI vs WFI, RNase/DNase/Protease Free — the R/D/P free variant includes additional testing with "None Detected" results for RNase, DNase, and Protease

Download technical datasheet for complete specifications

Quality & Manufacturing

  • Process: Reverse osmosis → continuous deionization → UV disinfection → distillation.
  • Facility: U.S. based cGMP facility; lots are fully traceable.
  • Safety: Not hazardous per GHS/HazCom; HMIS/NFPA ratings Health 0 / Flammability 0 / Physical Hazard 0.

Why Kodak

  • Heritage of Precision: Decades of expertise in high purity manufacturing for life sciences.
  • U.S.-based cGMP Facility: Consistent quality and full lot traceability.
  • Regulatory Confidence: cGxP compliant processes.
  • Customer Partnership: Technical support and responsive service for complex workflows.

Packaging, Storage & Shelf Life

  • Bottle size: 1 L
  • Storage: 15–30 °C (ambient); Operating: 15–38 °C.
  • Shelf life: Shown on label.

Ordering

Contact Sales: 1-800-356-3259

Frequently Asked Questions

Documents

To obtain a Certificate of Analysis (COA) please contact customer service at kodakpharma@kodak.com or 1-800-356-3259 and provide your lot number.
 

For Safety Data Sheets, please visit our database here.