UKRAINIAN PHARMACOPEYIA WATER QUALITY REQUIREMENTS |
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Highly purified water
Highly purified water is used for preparing medical drugs when the water of a higher biological quality is required, except those cases when only water for injection is used.
Production
Highly purified water is obtained from the drinkable water. During the production the two stage reverse osmosis both with other suitable methods is used. Those methods can be for example ultra-filtration and electric deionization. The proper technical maintenance and conditions are obligatory.
During the production and following storage there is provided the continuous monitoring and control of viable aerobic bacteria quantity. To monitor the unfavorable tendencies there is a special limit, which when exceeded requires the special measures. By the ordinary conditions this limit is the content of 10 viable aerobic bacterias in 100 ml of water. The estimation of bacteria content is rated by membranous filtration method, using the 200 ml of highly purified water and thick growth medium 5. Incubation is carried out during 5 days under the temperature from 30 °Ñ to 35 °Ñ.
The sought-for electrical conduction: not more than 1.1 µSm/cm under the temperature of 20 °Ñ; the content of carbon total organic: not more than 0.5 mg/l.
To ensure the proper water quality the validated procedures should be used, and there should be a regular control over the electric conductivity and microbiological purity during the production process.
Highly purified water is stored "in bulk" and it is used in conditions which prevent the growth of microorganisms and avoid any other pollutions.
Properties
transparent, colorless, odorless liquid.
Purity test
Nitrate. Not more 0.00002 % (0.2 ððò). 5 ml of a substance is filled into the test tube placed into an ice bath, then add 0.4 ml of potassium chloride (100 g/l), 0.1 ml of diphenylamine solution, 5 ml of nitrogen-free sulfuric acid. Then the test tube is placed into a water bath heated to 50 °Ñ; in 15 min the blue coloring should not be more reach than ethanol prepared at the same time with tested solution using the mixture of 4.5 ml of nitrate-free water, 0.5 ml of nitrate standard solution (2 ððò N0^).
Aluminum (2.4.17). 10 mkg/l, if the substance is for preparation of dialysis solutions.
Add 10 ml of acetate buffer solution pÍ 6.0 Ð and 100 ml of distilled water into 400 ml of a substance. The obtained solution is subject to the aluminum test. As a standard used the mixture of 2 ml of standard solution of aluminum (2 ððò À²), 10 ml of acetate buffer solution ðÍ 6.0 Ð and 98 ml of distilled water. The mixture of 10 ml of acetate buffer solution ðÍ 6.0 and 100 ml of distilled water is used as a compensating solution.
Heavy metals (2.4.8, method À). Not more than 0.00001 % (0.1 ððò). 200 ml is steamed in the glass evaporating dish on the water bath into 20 ml. 12 ml of an obtained solution should be subject to a test on heavy metals. Standard is prepared using 10 ml of lead standard solution (1 ððò ÐÜ).
Bacterial antitoxins (2.6.14). less than 0.25 ÌÎ/ml.
Marking
In cases of need the substance is marked as acceptable for dialysis solution production. |
