Water for Irrigation, USP, is a sterile, hypotonic, non-pyrogenic fluid or solvent.
- Medical Device Manufacturing
- Pharmaceutical API Manufacturing
- Process Equipment Cleaning & Rinsing
- USP and Product Release Testing
- Perfect for Buffer Preparation where Water for Injection is Not Required
- Applications Requiring Low Endotoxin Levels
- Manufactured under cGMP and ISO 13485 guidelines in a FDA registered facility
Water for Irrigation, USP, is a sterile, hypotonic, non-pyrogenic fluid or solvent. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is approximately 5.7 (5.0-7.0) and it complies with the United States Pharmacopoeia (USP) monograph testing for water for irrigation.
Sterile Water for Irrigation specific product test requirements and typical values are given below:
|Appearance||Visual||Clear and Colorless Liquid|
|Conductivity (Packaged)||USP <645>||<5.0 µS/cm|
|Endotoxin||USP <85>||<0.25 EU/mL|
|Oxidizable Substances||USP||The Pink Color does not Completely Disappear|
|Sterility||USP <71>||No Growth|
|TOC||USP <643>||<500 ppb|