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Water for Injection Specifications

The document outlines the specifications and requirements for Water for Injection, which must be purified by distillation or an equivalent process. It details specific tests for bacterial endotoxins, water conductivity, and total organic carbon, along with additional requirements for packaging, storage, and labeling. Water for Injection is intended for use in the preparation of parenteral solutions and must be protected from microbial contamination.

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Miyyada Aichaoui
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353 views1 page

Water for Injection Specifications

The document outlines the specifications and requirements for Water for Injection, which must be purified by distillation or an equivalent process. It details specific tests for bacterial endotoxins, water conductivity, and total organic carbon, along with additional requirements for packaging, storage, and labeling. Water for Injection is intended for use in the preparation of parenteral solutions and must be protected from microbial contamination.

Uploaded by

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

Printed on: Fri Jan 05 2024, 09:03:20 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-04FB68D0-C896-4513-B1BE-C82A0D442310_4_en-US

Printed by: USP NF Official Date: Official as of 01-Nov-2018 Document Type: USP & NF @2024 USPC
Do Not Distribute DOI Ref: k047f DOI: https://doi.org/10.31003/USPNF_M88820_04_01
1

addition to the Specific Tests, Water for Injection that is


Water for Injection packaged for commercial use elsewhere meets the
[NOTE—For microbiological guidance, see general additional requirements for Packaging and Storage and
information chapter Water for Pharmaceutical Purposes Labeling as indicated under Additional Requirements.]
á1231ñ.] SPECIFIC TESTS
H2O 18.02 [NOTE—Required for bulk and packaged forms of Water for
Injection.]
DEFINITION • BACTERIAL ENDOTOXINS TEST á85ñ: Less than 0.25 USP
Water for Injection is water purified by distillation or a Endotoxin Unit/mL
purification process that is equivalent or superior to • WATER CONDUCTIVITY, Bulk Water á645ñ: Meets the
distillation in the removal of chemicals and microorganisms. requirements
It is prepared from water complying with the U.S. • TOTAL ORGANIC CARBON á643ñ: Meets the requirements
Environmental Protection Agency National Primary Drinking
Water Regulations or with the drinking water regulations of ADDITIONAL REQUIREMENTS
the European Union or of Japan or with the World Health [NOTE—Required for packaged forms of Water for
Organization’s Guidelines for Drinking Water Quality. It Injection.]
contains no added substance. • PACKAGING AND STORAGE: Where packaged, preserve in
[NOTE—Water for Injection, whether it is available in bulk or unreactive storage containers that are designed to prevent
packaged forms, is intended for use in the preparation of microbial entry.
parenteral solutions. Where used for the preparation of • LABELING: Where packaged, label the article to state that it
parenteral solutions subject to final sterilization, use contains no antimicrobial or other substance, and that it is
suitable means to minimize microbial growth, or first not intended for direct parenteral administration.

al
render the Water for Injection sterile and, thereafter,
protect it from microbial contamination. For parenteral Delete the following:
solutions that are prepared under aseptic conditions and
are not sterilized by appropriate filtration or in the final
▲
• USP REFERENCE STANDARDS á11ñ
container, first render the Water for Injection sterile and, ci USP 1,4-Benzoquinone RS▲ (ERR 1-Nov-2018)
thereafter, protect it from microbial contamination. In
ffi
O

https://online.uspnf.com/uspnf/document/1_GUID-04FB68D0-C896-4513-B1BE-C82A0D442310_4_en-US 1/1

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