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Water for Hemodialysis
NOTE—See Water for Health Applications 1230 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.
Microbial limits 61 The total viable count does not exceed 100 cfu per mL.
Bacterial endotoxins 85 It contains less than 2 USP Endotoxin Units per mL.
Water conductivity 645: meets the requirements.
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Oxidizable substances— To 100 mL, add 10 mL of 2 N sulfuric acid, and heat to boiling. Add 0.2 mLUSP29 of 0.1 NUSP29 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