Water for Hemodialysis
NOTE—See Water for Health Applications á1230ñfor 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,which 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 at room temperature in unreactive storage containers that are designed to prevent bacterial entry.
Microbial limits á61ñ— The total viable count does not exceed 100cfu per mL.
Bacterial endotoxins á85ñ— It contains not more than 2USP Endotoxin Units per mL.
Water conductivity á645ñ: meets the requirements.
Oxidizable substances— To 100mL,add 10mLof 2Nsulfuric acid,and heat to boiling.Add 0.1mLof 0.1Npotassium permanganate,and boil for 5minutes.The pink color does not completely disappear;or alternatively follow the test method for Total Organic Carbon á643ñ.
Auxiliary Information— Staff Liaison:Francis P.Barletta
Expert Committee:(PW)Pharmaceutical Waters
USP28–NF23Page 2036
Pharmacopeial Forum:Volume No.30(4)Page 1317
Phone Number:1-301-816-8328
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