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USP Purified Water

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.

Applicable Standards

  • USP 643

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
PWA120 USP/EP Purified Water Test: TOC/Conductivity/EP nitrates/heavy metals 7 Add
PWA125 USP/EP Purified Water Test: EP nitrates and heavy metals only 7 Add
PWA305 USP Water Analysis: Purified Water study (TOC/Conductivity) 5 Add
PWA330 USP Water Analysis: Sterile Water for Injection 7 Add
PWA350 USP Water Analysis: USP or EP custom Protocol 21 Add
PWA435 USP Water Analysis: Chemical tests, Oxidizable substances 7 Add
PWA500 EP Water Analysis: Sterilized water for injection, monograph 14 Add
PWA120 - USP/EP Purified Water Test: TOC/Conductivity/EP nitrates/heavy metals
7 days
PWA125 - USP/EP Purified Water Test: EP nitrates and heavy metals only
7 days
PWA305 - USP Water Analysis: Purified Water study (TOC/Conductivity)
5 days
PWA330 - USP Water Analysis: Sterile Water for Injection
7 days
PWA350 - USP Water Analysis: USP or EP custom Protocol
21 days
PWA435 - USP Water Analysis: Chemical tests, Oxidizable substances
7 days
PWA500 - EP Water Analysis: Sterilized water for injection, monograph
14 days

Sample Specifications

PWA125: 500 mL

Study Outline

USP 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.
 
Conductivity
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 Water Analysis Chart
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           
TOC X X X X          
Conductivity X X X X X X X X  
Endotoxins   X X X   X X X X
Oxidizable Substances         X X X X  
Sterility         X X X X X
Microbial Enumeration       X          
Particulates           X     X
Antimicrobial Agents                 X
pH                 X
Calcium                 X
Carbon Dioxide                 X
Sulfates                 X
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.