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Sterile Water for Injection Guidelines

Sterile Water for Injection is defined as water for injection that has been sterilized and packaged. It contains no added antimicrobial agents or other substances. The document provides acceptance criteria and requirements for Sterile Water for Injection, including passing tests for total organic carbon, water conductivity, particulate matter, sterility, and bacterial endotoxins. Glass or plastic single-dose containers of 1 L or less are specified for packaging and storage, and labeling must indicate no added substances and unsuitability for direct intravenous injection.

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230 views1 page

Sterile Water for Injection Guidelines

Sterile Water for Injection is defined as water for injection that has been sterilized and packaged. It contains no added antimicrobial agents or other substances. The document provides acceptance criteria and requirements for Sterile Water for Injection, including passing tests for total organic carbon, water conductivity, particulate matter, sterility, and bacterial endotoxins. Glass or plastic single-dose containers of 1 L or less are specified for packaging and storage, and labeling must indicate no added substances and unsuitability for direct intravenous injection.

Uploaded by

siroratss
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd

Printed on: Tue Aug 03 2021, 07:32:11 AM Official Status: Currently Official on 03-Aug-2021 DocId: 1_GUID-4C5C108F-3C39-4310-A584-63289DF582C4_5_en-US

(EST)
Printed by: Le Tran Official Date: Official as of 01-May-2021 Document Type: USP & NF @2021 USPC
1

Acceptance criteria: The pink color does not completely


Sterile Water for Injection disappear. Alternatively, perform the test for Total Organic
[NOTE—For additional information, see Water for Carbon á643ñ, Sterile Water.▲ (USP 1-May-2021)
Pharmaceutical Purposes á1231ñ.]
Change to read:
H2O 18.02
• TOTAL ORGANIC CARBON á643ñ, Procedures, Sterile Water:
DEFINITION Meets the requirements▲▲ (USP 1-May-2021)
Sterile Water for Injection is prepared from Water for Injection • WATER CONDUCTIVITY á645ñ, Sterile Water: Meets the
that is sterilized and suitably packaged. It contains no requirements
antimicrobial agent or other added substance. • PARTICULATE MATTER IN INJECTIONS á788ñ: Meets the
SPECIFIC TESTS requirements
• STERILITY TESTS á71ñ: Meets the requirements
Delete the following: • BACTERIAL ENDOTOXINS TEST á85ñ: Less than 0.25 USP
Endotoxin Units/mL
▲
• OXIDIZABLE SUBSTANCES
Sample: 100 mL ADDITIONAL REQUIREMENTS
Analysis: Add 10 mL of 2 N sulfuric acid, and heat to a boil. • PACKAGING AND STORAGE: Preserve in single-dose glass or
For Sterile Water for Injection in containers having a fill plastic containers of not larger than 1-L size. Glass
volume less than 50 mL, add 0.4 mL of 0.02 M potassium containers are preferably of Type I or Type II glass.
permanganate, and boil for 5 min; where the fill volume is • LABELING: Label it to indicate that no antimicrobial or other
50 mL or more, add 0.2 mL of 0.02 M potassium substance has been added, and that it is not suitable for
permanganate, and boil for 5 min. If a precipitate forms, intravascular injection without first having been made

al
cool in an ice bath to room temperature, and pass approximately isotonic by the addition of a suitable solute.
through a sintered-glass filter.

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https://online.uspnf.com/uspnf/document/1_GUID-4C5C108F-3C39-4310-A584-63289DF582C4_5_en-US 1/1

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