Water for Injection, Aseptic Filled (WFI)
Product Description
Water for Injection (WFI), Aseptic Filled, is a sterile, non-pyrogenic, ultrapure water that meets the specifications of the United States Pharmacopeia (USP) for Water for Injection. It is aseptically processed and packaged under controlled conditions without terminal sterilization, ensuring it remains suitable for use in the compounding of parenteral (injectable) preparations.
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:
Intended for use as a sterile solvent or diluent in the preparation of injectable drugs or biologics, and in other pharmaceutical manufacturing processes requiring sterile, endotoxin-controlled water.
Features:
- USP-compliant Water for Injection
- Sterile and non-pyrogenic
- Aseptically filled – no terminal sterilization
- Free of antimicrobial agents or preservatives
- Suitable for pharmaceutical compounding and manufacturing
Intended Use:
For use in the preparation of parenteral products where sterility is essential. Not for direct intravenous administration unless properly combined with suitable solutes.
Packaging:
Storage:
Store at controlled room temperature. Protect from freezing and excessive heat. Use immediately after opening; discard unused portion.
Caution:
For use by qualified healthcare professionals. Not to be administered alone intravenously. Use only as directed and in accordance with compounding regulations.
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