Resistivity: ≥0.5MΩ.CM, Conductivity: ≤2μS Ammonia ≤0.3μg/ml Nitrate ≤0.06μg/ml Heavy metal ≤0.5μg/ml

Edit this paragraph four, pharmaceutical water classification and water quality standards

1. Classification of pharmaceutical water

(Process water: water used in the production process of pharmaceuticals, including drinking water, purified water, water for injection)

1) Drinking water (Potable-Water): Tap water or deep well water, also known as raw water, usually supplied by the water company. Its quality must conform to the national standard GB5749-85 "Sanitary Standard for Drinking Water". According to the 2005 Chinese Pharmacopoeia, drinking water cannot be directly used as preparation or test water for preparations.

2) Purified Water: Pharmaceutical water obtained by distillation, ion exchange, reverse osmosis or other suitable methods, without any additives. Purified water can be used as a solvent or test water for formulating common pharmaceutical preparations. It should not be used for the preparation of injections. Purified water prepared by non-heat treatment such as ion exchange method, reverse osmosis method or ultrafiltration method is generally called deionized water. Purified water prepared by distillation using a specially designed distiller is also generally referred to as distilled water.

3) Water for Injection: Water obtained by purifying the purified water as a raw water, distilling it through a specially designed distiller, cooling and cooling, and then filtering through a membrane. Water for injection can be used as a solvent for formulating an injection.

4) Sterile Water for Injection: The water obtained by the injection production process is water for injection. Sterilized water for injection is used as a diluent for the solvent or injection of the sterilized powder.

2. Water quality standards for pharmaceutical water

1) Drinking water: It should meet the national standard of the People's Republic of China, "Sanitary Standard for Drinking Water" (GB5749-85)

2) Purified water: It should meet the purified water standard contained in the 2005 Chinese Pharmacopoeia. In the water production process, the value of the resistivity of the purified water is usually detected online to reflect the concentration of various ions in the water. The resistivity of purified water in the pharmaceutical industry should generally be ≥0.5MΩ.CM/25°C, and the resistivity of purified water for injection and eye container should be ≥1MΩ.CM/25°C.

3) Water for injection: It should meet the standard of water for injection contained in the 2005 Chinese Pharmacopoeia.

Edit this paragraph five, the 2005 version of the Pharmacopoeia analysis of pharmaceutical water requirements

GMP basic certification procedures for purified water equipment

Pre-confirmation installation confirmation document required for installation confirmation

Confirmation of critical instruments and verification of installation verification of purified water preparation equipment

Installation of the pipeline distribution system confirms the cleaning and disinfection of the pipeline

Tank vent filter integrity test run confirmation

Detection of system operating parameters

Pre-test analysis performance confirmation of purified water quality

Confirmation of performance of equipment performance

Sampling point and sampling frequency detection item detection method

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