Water for Hemodialysis
[Note—See Water for Hemodialysis Applications 1230 for guidelines on microbial and chemical testing. ]
Change to read:

H2O 18.02(ERR 1-Oct-2014)
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 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.
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in unreactive storage containers that are designed to prevent bacterial entry. Store at room temperature.
•  USP Reference Standards 11
USP 1,4-Benzoquinone RS Click to View Structure
USP Endotoxin RS
USP Sucrose RS Click to View Structure
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
(301) 816-8308
(GCCA2010) General Chapters - Chemical Analysis
61 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(301) 816-8339
(GCM2010) General Chapters - Microbiology
62 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(301) 816-8339
(GCM2010) General Chapters - Microbiology
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(301) 816-8339
(GCM2010) General Chapters - Microbiology
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP38–NF33 Page 5805
Pharmacopeial Forum: Volume No. 35(6) Page 1485