ULTRA
|
| PACKAGED PRODUCT ANALYSIS |
METHOD OF REFERENCE |
SPECIFICATION |
| Appearance |
Visual |
Clear & Colorless Liquid |
| Total Organic Carbon |
USP <643> |
< 8000 ppb |
| Conductivity |
USP <645> |
≤ 5 µS/cm |
| Particulate Matter |
USP <788> |
| ≥ 25 µm in size |
≤ 3 particles/mL |
|
| ≥ 10 µm in size |
≤ 25 particles/mL |
|
| Endotoxin |
USP <85> |
≤ 0.05 EU/mL1 |
| Sterility |
USP <71> |
No Growth |
1 The USP specification for Sterile Grade Water for Injection requires endotoxin levels to be less than 0.25 EU/mL. Aquabiliti applies a tightened specification, limiting endotoxin to less than 0.05 EU/mL.
| WFI Generation Online Analysis |
 |
WFI-USP |
| Conductivity (µS/cm) |
≤ 0.06 µS/cm |
≤ 1.3 µS/cm |
| TOC |
≤ 20 ppb |
< 500 ppb |