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Pharmaceutical water quality index
Publisher: Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd Time：2023-03-07 15:16:24 Number of clicks：252 Close
Pharmaceutical process water usually refers to drinking water, purified water, water for injection and sterilization water for injection four categories, then the pharmaceutical industry on water equipment and water quality index purification and what requirements?
I. Pharmaceutical water classification and water quality index
1, pharmaceutical water (process water: water, including drinking water, purified water, water injection) classification
1) Drinking water (drinking water) : tap water or deep well water, which is usually provided by the water supply company, or deep water, also known as raw water, whose quality must meet the national standard GB5749-85 "Sanitary Standard for Drinking Water".
2) Water by distillation, ion exchange, reverse osmosis or other suitable methods, without any additives. The purified water can be used as a solvent or test water for the preparation of common pharmaceutical preparations, but not for the preparation of pharmaceutical preparations.
The preparation of purified water by ion exchange, reverse osmosis and ultrafiltration is generally called deionized water. Pharmaceutical water purification equipment is designed with a special distillation process, the distillation process of distilled water is generally called distilled water
3) Water for Injection: water is prepared by purifying water as raw water, distilled, condensed and cooled by a specially designed still, and then filtered by membrane.
Water for injection can be used as a solvent for preparing injections.
4) Sterile Water for Injection: Water prepared for injection in accordance with the sterile production process.
Sterilizing water for injection A solvent used to sterilize powder or a diluent for injection.
2, pharmaceutical water quality standards
1) Drinking water: It shall conform to the national standard of the People's Republic of China "Sanitary Standard for Drinking Water" (GB5749-85).
2) Purified water: It shall comply with the purified water standards contained in 2000 Chinese Pharmacopoeia.
In the process of water preparation, the resistivity value of purified water is usually detected online to reflect the concentration of various ions in the water. The electrical resistivity of purified water used in pharmaceutical industry should be ≥0.5 mω.cm /25℃, and that of purified water used for irrigation of injection and eye drop containers should be ≥1 mω.cm /25℃.
3) Water for injection: It shall meet the water for injection standards listed in 2000 Chinese Pharmacopoeia.
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