Water for Hemodialysis

[Note—See Water for Hemodialysis Applications

for guidelines on microbial and chemical testing. ]

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.

SPECIFIC TESTS

• Total Organic Carbon

643

: Meets the requirements

• Microbial Enumeration Tests

and Tests for Specified Microorganisms

: 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

: It contains less than 1 USP Endotoxin Unit/mL.

ADDITIONAL REQUIREMENTS

• Packaging and Storage: Preserve in unreactive storage containers that are designed to prevent bacterial entry. Store at room temperature.

• USP Reference Standards

USP 1,4-Benzoquinone RS

USP Endotoxin RS

USP Sucrose RS

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Antonio Hernandez-Cardoso, M.Sc. Senior Scientific Liaison 1-301-816-8308	(GCCA2010) General Chapters - Chemical Analysis
61	Radhakrishna S Tirumalai, Ph.D. Principal Scientific Liaison 1-301-816-8339	(GCM2010) General Chapters - Microbiology
62	Radhakrishna S Tirumalai, Ph.D. Principal Scientific Liaison 1-301-816-8339	(GCM2010) General Chapters - Microbiology
85	Radhakrishna S Tirumalai, Ph.D. Principal Scientific Liaison 1-301-816-8339	(GCM2010) General Chapters - Microbiology
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org

USP35–NF30 Page 5039

Pharmacopeial Forum: Volume No. 35(6) Page 1485