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PURIFIED WATER IN CONTAINERS

Category Pharmaceutic aid.

      Purified Water in Containers is Purified Water in bulk that has been filled and stored in conditions designed to assure the required microbiological quality. It contains no added substances.

Description Clear, colourless liquid; odourless.

Packaging and storage Purified Water in Containers shall be kept in unreactive storage containers that are designed to prevent microbial entry.

Labelling The label on the container states (1) the method of preparation; (2) that it is not for parenteral administration.

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 Sterile 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).

 

MONOGRAPHS • PURIFIED WATER IN CONTAINERS
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หมายเหตุ / Note : TP II 2011 PAGE 143