USP Monographs: Water for Hemodialysis

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 limits

— 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.

Change to read:

Oxidizable substances— To 100 mL, add 10 mL of 2 N sulfuric acid, and heat to boiling. Add

0.2 mL

USP29 of

0.1 N

USP29 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— Staff Liaison : Gary E. Ritchie, M.Sc., Scientific Fellow

Expert Committee : (PW05) Pharmaceutical Waters 05

USP29–NF24 Page 2266

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

Phone Number : 1-301-816-8353