USP (United States Pharmacopeia) Water Specifications
The specifications for various types of pharmaceutical-grade water according to the United States Pharmacopeia (USP) are presented in the tables below.
Purified Water (PW):
| Parameter |
Specification |
| Total Organic Carbon (TOC) |
≤500 ppb |
| Conductivity |
≤1.3 µS/cm at 25°C |
| pH |
5.0-7.0 |
| Chloride |
≤0.5 mg/l |
| Sulfate |
≤1.0 mg/l |
| Ammonia |
≤0.03 mg/l |
| Calcium |
≤1.0 mg/l |
| Total Viable Aerobic Count |
≤ 100 CFU/mL |
| Total Combined Molds and Yeasts Count |
≤10 CFU/mL |
| Absence of Specified Microorganisms |
Escherichia coli, Salmonella species, Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogenic or indicator organisms. |
Water for Injection (WFI):
| Parameter |
Specification |
| Total Organic Carbon (TOC) |
≤500 ppb |
| Conductivity |
≤1.3 µS/cm at 25°C |
| pH |
5.0-7.0 |
| Bacterial Endotoxins |
≤0.25 EU/mL |
| Total Viable Aerobic Count |
≤ 10 CFU/100mL |
Sterile Water for Injection (SWFI):
| Parameter |
Specification |
| Total Organic Carbon (TOC) |
≤500 ppb |
| Conductivity |
≤1.3 µS/cm at 25°C |
| pH |
5.0-7.0 |
| Bacterial Endotoxins |
≤0.25 EU/mL |
| Total Viable Aerobic Count |
Free from viable microorganisms |
Sterile Purified Water (SPW):
| Parameter |
Specification |
| Total Organic Carbon (TOC) |
≤500 ppb |
| Conductivity |
≤1.3 µS/cm at 25°C |
| pH |
5.0-7.0 |
| Chloride |
≤0.5 mg/l |
| Sulfate |
≤1.0 mg/l |
| Ammonia |
≤0.03 mg/l |
| Calcium |
≤1.0 mg/l |
| Total Viable Aerobic Count |
Free from viable microorganisms |