Water for Hemodialysis

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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[NOTE-See Water for Hemodialysis Applications (1230) for guidelines on microbial and chemical testing.]

H₂O           18.02

1 DEFINITION

Water for Hemodialysis is water that complies with the U.S. Environmental Protection Agency National Primary Drinking Water Regulations and that has been subjected to further treatment, using a suitable process, to reduce chemical and microbiological components. It is produced and used onsite under the direction of qualified personnel. It contains no added antimicrobials and is not intended for injection.

2 SPECIFIC TESTS

TOTAL ORGANIC CARBON (643): Meets the requirements

MICROBIAL ENUMERATION TESTS (61) and TESTS FOR SPECIFIED MICROORGANISMS (62): The total aerobic microbial count does not exceed 100 cfu/mL. It meets the requirements of the test for absence of Pseudomonas aeruginosa.

WATER CONDUCTIVITY, Bulk Water (645): Meets the requirements

BACTERIAL ENDOTOXINS TEST (85): It contains less than 1 USP Endotoxin Unit/mL.

3 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in unreactive storage containers that are designed to prevent bacterial entry. Store at room temperature.

Delete the following:

^▲USP REFERENCE STANDARDS (11)

USP 1,4-Benzgouinone RSA _{▲(ERR 1-Nov-2018)}