European Union drinking water

Water for injection (WFI) is the most widely used solvent for parenteral preparations. The USP requirements for WFI and purified water have been recently updated to replace the traditional wet and colorimetric analytical methods with the more modern and cost-effective methods of conductivity and total organic carbon. Water for injection must be prepared and stored in a manner to ensure purity and freedom from pyrogens. The most common means of obtaining WFI is by the distillation of deionized water. This is the only method of preparation permitted by the European Pharmacopoeia (EP). In contrast, the USP and the Japanese Pharmacopeias also permit reverse osmosis to be used. The USP has also recently broadened its definition of source water to include not only the U.S. Environmental Protection Agency National Primary Drinking Water Standards, but also comparable regulations of the European Union or Japan. 

Purified water is water obtained by a suitable process. It is prepared from water complying with the U.S. Environmental Protection Agency National Primary Drinking Water Regulations or comparable regulations of the European Union or Japan. It contains no added substances. 

Saponins for beverage use are sourced from quillaia bark (Quillaia saponaria Molina) and the yuccas. Of the latter species, two main varieties are used in the United States for production of the water extract the Mohave yucca (Yucca mohavensis) and the Joshua tree (Yucca brevifolia). At the levels used these additives are colourless and tasteless the dried extract, however, possesses an acrid, astringent taste. Permitted limits are quoted in terms of the dry weight of the extract. In the European Union, subject to Directive 95/2/EC, quillaia is permitted only in non-alcoholic drinks, to a maximum level of 200 mg/1. 

The European Union has an arsenic drinking water standard of 10pgl 1 (European Union, 1998 Table 5.1). 

In the case of Cd in drinking water the performance criteria are clearly speci-bed as 10 percent for both trueness and precision. Therefore, it is rather surprising to see PT providers stating assigned standard deviations of 5, 7, 10, or even 14 percent for Cd in water, in compliance with the WFD. This is because some PT providers only consider trueness, others, in turn, combine trueness and precision. Some consider precision properly, others take it as a direct estimate of the normalization factor. To improve such situations, the European Union initiated the CoEPT project to study the differences and similarities in the operation of PT schemes and the evaluation of PT results in view of implementing a harmonized approach to provide a basis for the comparability of the PT schemes operated on the market [70]. 

Palacios, M., Pampillon, J.F. and Rodriguez, M.E. (2000) Organohalogenated compounds levels in chlorinated drinking water and current compliance with quality standards throughout the European Union. Water Res. 34, 1002-1016. 

UK,DRINKING WATER INSPECTORATE EUROPEAN COMMUNITY EUROPEAN UNION UK WESTERN EUROPE... 

In the European Union, because of the general view that there should be no pesticides in drinking water, a precautionary principle is applied, and standards are set as low as is reasonably achievable. EEC directive 98/83/CE for drinking water therefore set limit values at 0.1 /rg/1 for each individual pesticide and 0.5 /rg/1 for total pesticides. For surface water used to produce drinking water, these values are 2 /rg/1 for each individual substance and 5 /rg/1 for total pesticides. 

Potable water should be supplied under continuous positive pressure in a plumbing system free from defects that could lead to the contamination of APIs or intermediates. Potable water should meet the standards prescribed in the Environmental Protection Agency s Primary Drinking Water Regulations (Title 40, Code of Federal Regulations, Part 141). Potable water in facilities outside the United States should meet comparable standards of the European Union, Japan, the World Health Organization, or other authorities. Drains should be of adequate size and provided with an air break or suitable mechanical device to prevent back-siphonage. 

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