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WATER FOR HEMODIALYSIS

Category Hemodialysis solution

      Water for Hemodialysis is water that complies with the regulation on water intended for human consumption laid down by the competent authority 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.

Description Clear, colourless liquid; odourless.

Packaging and storage Water for Hemodialysis shall be kept in unreactive storage containers that are designed to prevent bacterial entry and stored at room temperature.

Oxidizable substances To 100 ml, add 10 ml of 1 M sulfuric acid, and heat to boiling. Add 0.20 ml of 0.020 M potassium permanganate, and boil for 5 minutes. The pink colour does not completely disappear. Alternatively the test method for Total Organic Carbon (Appendix 4.36) may be performed.

Water conductivity Complies with the “Water Conductivity” (For Bulk Water, Appendix 4.37).

Microbial limit Total aerobic microbial count does not exceed 2×102 CFU per ml, determined by membrane filtration (Appendix 10.2).

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains less than 2.0 Endotoxin Units per ml.

MONOGRAPHS • WATER FOR HEMODIALYSIS
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หมายเหตุ / Note : TP II 2011 PAGE 173