Water for Hemodialysis

for guidelines on microbial and chemical testing.

» 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.

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

USP Reference standards

—
USP Endotoxin RS.

Microbial enumeration tests

and Tests for specified microorganisms

— The total viable count does not exceed 100 cfu per mL.

Bacterial endotoxins

— It contains less than 2 USP Endotoxin Units per mL.

Water conductivity

645

: meets the requirements.

Oxidizable substances— To 100 mL, add 10 mL of 2 N sulfuric acid, and heat to boiling. Add 0.2 mL of 0.02 M potassium permanganate, and boil for 5 minutes. The pink color does not completely disappear; or alternatively follow the test method for Total Organic Carbon

643

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

Topic/Question	Contact	Expert Committee
Monograph	Gary E. Ritchie, M.Sc. Scientific Fellow 1-301-816-8353	(PW05) Pharmaceutical Waters 05
Reference Standards	Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org
61	Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339	(MSA05) Microbiology and Sterility Assurance
62	Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339	(MSA05) Microbiology and Sterility Assurance
85	Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339	(MSA05) Microbiology and Sterility Assurance

USP32–NF27 Page 3872

Pharmacopeial Forum: Volume No. 31(2) Page 468