USP Purified Water
USP Purified Water testing evaluates purified water used in non-parenteral preparations, cleaning of equipment and other non-parenteral product-contact components. Unless otherwise noted, purified water is used for all tests and assays for which water is indicated, including the preparation of non-monographed analytical waters.
Testing includes Conductivity and Total Organic Carbon (TOC) analyses, which measure the water’s ionic and organic chemical purity, respectively. The measurement of product conductivity and organic carbon molecules is a typical way to monitor and trend the performance of validated water purification systems.
This test was written in compliance with the USP standard of Purified Water. Nelson Laboratories has extensive experience performing this type of testing and consulting on water system validations. Our state-of-the-art TOC analyzers are capable of detecting TOC in the ppb range.
- USP 643
Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.
|PWA120||USP/EP Purified Water Test: TOC/Conductivity/EP nitrates/heavy metals||Add|
|PWA125||USP/EP Purified Water Test: EP nitrates and heavy metals only||Add|
|PWA305||USP Water Analysis: Purified Water study (TOC/Conductivity)||Add|
|PWA330||USP Water Analysis: Sterile Water for Injection||Add|
|PWA350||USP Water Analysis: USP or EP custom Protocol||Add|
|PWA435||USP Water Analysis: Chemical tests, Oxidizable substances||Add|
|PWA500||EP Water Analysis: Sterilized water for injection, monograph||Add|
PWA120 - USP/EP Purified Water Test: TOC/Conductivity/EP nitrates/heavy metals
TAT: 7 days
PWA125 - USP/EP Purified Water Test: EP nitrates and heavy metals only
TAT: 7 days
PWA305 - USP Water Analysis: Purified Water study (TOC/Conductivity)
TAT: 5 days
PWA330 - USP Water Analysis: Sterile Water for Injection
TAT: 7 days
PWA350 - USP Water Analysis: USP or EP custom Protocol
TAT: 21 days
PWA435 - USP Water Analysis: Chemical tests, Oxidizable substances
TAT: 7 days
PWA500 - EP Water Analysis: Sterilized water for injection, monograph
TAT: 14 days
PWA125: 500 mL
Study OutlineUSP Purified Water testing is performed on water which has been purified using unit operations that include deionization, distillation, ion exchange, reverse osmosis, filtration or other suitable purification procedures. It must meet requirements for ionic and organic chemical purity, as determined in the Conductivity test and Total Organic Carbon (TOC) test, respectively.
Electrical conductivity in water is a measure of the ion-facilitated electron flow through it. The sample must meet the requirements in USP <645> when tested according to the current version of the NLI STP for Conductivity. Read the complete study outline on conductivity testing.
Total Organic Carbon (TOC)
TOC is the amount of carbon bound in an organic compound and is used as a non-specific indicator of water quality or cleanliness. The sample must meet the requirements in USP <643> when tested according to the current version of the NLI STP for Total Organic Carbon. Read the complete study outline on TOC testing.
|USP Monograph||Purified Water||Water for Injection||Pure Steam||Water for Hemodialysis||Sterile Purified Water||Sterile Water for Injection||
Sterile Water for Irrigation
||Sterile Water for Inhalation||Bacteriostatic Water for Injection|
|Minimum Sample Amount||155 ml||160 ml||160 ml||210 ml||210 ml + sterility*||240 ml + sterility*||215 ml + sterility*||215 ml + sterility*||485 ml + sterility*|
|* Contact Nelson Laboratories for sterility sample amount required.|