Water for Injection, Terminally Sterilized (WFI)
Product Description
Water for Injection, Terminally Sterilized (WFI), is a sterile, non-pyrogenic water that meets the specifications of the United States Pharmacopeia (USP) for Water for Injection. This product has undergone terminal sterilization in its final container to ensure sterility and endotoxin control. It contains no antimicrobial agents, buffers, or added solutes and is intended for use as a diluent or solvent in the preparation of injectable pharmaceutical products.
BOTTLES
100 mL
250 mL
500 mL
1 L
BAGS
10 L
20 L
200 L (drum)
TOTES
available
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Specifications
Parameter
Specification Range
Conductivity
TOC
Up to 500 ppb
Bioburden
< 10 CFU/100mL
Endotoxin
< 0.25 EU/mL
Indications:
Used for reconstituting and diluting parenteral (injectable) drugs intended for intravenous, intramuscular, or subcutaneous administration. Also suitable for use in sterile pharmaceutical compounding where Water for Injection is required.
Features:
- USP-compliant Water for Injection
- Terminally sterilized in the final container
- Sterile and non-pyrogenic
- Free of preservatives and additives
- Ensures high sterility assurance level (SAL)
- Single-use only
Intended Use:
For use in the preparation of parenteral solutions. Not intended for direct intravenous administration unless mixed with appropriate solutes to achieve isotonicity.
Packaging:
Storage:
Store at controlled room temperature (15°C to 30°C / 59°F to 86°F). Protect from freezing and direct light. Discard any unused portion after opening.
Caution:
Not for direct injection unless properly reconstituted with suitable pharmaceutical agents. For use by trained healthcare professionals. Improper use may cause hemolysis or other adverse effects.
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