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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