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:
| Parameter | Method | Specification |
|---|---|---|
| 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 |
| pH | USP <791> | 5.0-7.0 |
| Sterility | USP <71> | No Growth |
| TOC | USP <643> | <500 ppb |
