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What are the pharmaceutical water classification and water quality standards?

Jan 15, 2019

1. Classification of pharmaceutical water

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

1) potable-water: tap Water or deep well Water, also known as raw Water, which is usually supplied by a Water company, must meet the national standard gb5749-85 < hygienic standard for domestic drinking Water ".

According to the 2005 Chinese pharmacopoeia, drinking water cannot be directly used for preparation or testing of preparations.

2) PurifiedWater: it is the water used in pharmaceuticals after distillation, ion exchange, reverse osmosis or other appropriate methods, and it does not contain any additive.

Purified water may be used as solvent or test water for the preparation of ordinary pharmaceutical preparations, and shall not be used for the preparation of injections

Purified water prepared by ion exchange, reverse osmosis, ultrafiltration and other non-heat treatment methods is commonly known as deionized water.

reverse osmosis equipment

Purified water produced by distillation in a specially designed distiller is generally called distilled water.

3) WaterforInjection: the purified water is used as raw water, which is distilled by a specially designed distiller, condensed and cooled, and then prepared by membrane filtration.

Water for injection can be used as solvent for preparing injection.

4) SterileWaterforInjection: is water that is prepared with water for injection according to the injection production process.

Water for sterile injection is used as a solvent for sterilizing powder or as a diluent for injection.