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Water for Injection, USP

Water for Injection, USP

The USP Water for Injection test validates water which has been purified by distillation, or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms.

This test ensures that finished water meets the chemical requirements for purified water, as well as meeting the requirement for bacterial endotoxin levels. Testing meets the USP water monograph and is performed on water and bulk water.

Applicable Standards

  • USP 645

Test Options

Standard turn around times (TAT) are listed below. 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.

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
PWA320 USP Water Analysis: Water for Injection (LAL/TOC/Conductivity) 7 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
TAT: 7 days
PWA125 - USP/EP Purified Water Test: EP nitrates and heavy metals only
TAT: 7 days
PWA320 - USP Water Analysis: Water for Injection (LAL/TOC/Conductivity)
TAT: 7 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

Sample Specifications

PWA125: 500 mL
PWA320: 155 mL; please use appropriate sampling bottles.

Study Outline

USP Water for Injection testing includes bacterial endotoxins testing (LAL) and conductivity and total organic carbon (TOC) analyses, which measure the endotoxin content, ionic and organic chemical purity, respectively.

Bacterial Endotoxins
The Limulus Amebocyte Lysate (LAL) test is an in vitro assay for detection and quantitation of bacterial endotoxin. Validated test methods performed at Nelson Laboratories include the gel clot technique and the kinetic turbidimetric and chromogenic (colorimetric) assays. Read the complete study outline on Baceterial Endotoxin testing.

The sample must not contain more than 0.25 USP Endotoxin Unit per ml when tested according to the current version of the NLI STP for Bacterial Endotoxins.

Conductivity
Electrical conductivity in water is a measure of the ion-facilitated electron flow. The measurement of the ions with their resulting conductivity is an indication of water purity. Read the complete study outline on Conductivity testing.

The sample must meet the requirements in USP <645> when tested according to the current version of the NLI STP for Conductivity.

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. Read the complete study outline on TOC testing.

The sample must meet the requirements in USP <643> when tested according to the current version of the NLI STP for Total Organic Carbon.



 

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.
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