Voda (Aqua)
USP 37 〈1231〉 WATER FOR PHARMACEUTICAL PURPOSES
Ph. Eur. 6,3 01/2009/0008 Aqua purificata
The International Pharmacopoeia – Fifth Edition, 2015 Purified water (Aqua purificata)
USP29 Purified Water
USP29 WATER FOR PHARMACEUTICAL PURPOSES
USP Standards for Purifed Water
Purified Water is to be used in the production or compounding of USP products. Manufacturing is controlled by the FDA, while compounding is controlled at the state level by the boards of pharmacy.
The following are numerical value limits that are commonly used interpretations* of the procedures listed on pages 1752 and 1753 under the individual monographs:
| pH | 5.0 to 7.0 |
| Chloride (mg/l) | 0.5 |
| Sulfate (mg/l) | 1.0 |
| Ammonia (mg/l) | 0.03 |
| Calcium (mg/l) | 1.0 |
| Carbon Dioxide (mg/l) | 5.0 |
| Oxidizable Substances | Pass the USP Permanganate test |
| Bacteria | Purified Water (CFU/ml) 100WFI (CFU/100ml) 10
Sterile PW — Pass the USP Sterility test <71> |
| Endotoxin WFI (EU/ml) | 0.25 |
Note: Purified Water and Sterile Purified Water may be “obtained by any suitable process”. Water for Injection is “water purified by distillation or reverse osmosis”.
These limits are Guidelines found in General Chapter <1231>
The “wet” chemistry tests and the oxidizable substance test in the USP23 monographs for PW and WFI were deleted. They were replaced with a Water Conductivity test for ionic impurities and a Total Organic Carbon test (TOC) for organic impurities.
The current standards for PW and WFI are:
| TOC | < 500 ppb Carbon |
| Conductivity | < 1.3 TS / cm @ 25° |
| <1.1 TS / cm @ 20° | |
| Bacteria | < PW-100 cfu/mL |
| (guidelines in <1231>) | <WFI-10 cfu/100mL |
| Bacterial Endotoxins | <WFI-0.25 USP Eu/mL |
USP24 contains complete versions of all pharmaceutical water monographs p. 1752-1754 and the general chapters <643> TOC, <645> Water Conductivity p. 1927-1929, and <1231> Water for Pharmaceutical Purposes p. 2154-2163.
Purified Water may be produced by any suitable process. WFI must be produced by distillation or reverse osmosis only.