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Pharmaceutical Purified Water System
Water Quality Difference Between Water for Injection and Purified Water
  If we compare the water quality standards of purified water and water for injection in the United States Pharmacopoeia, we can see the main differences between them. Their physical and chemical indexes are the same, but the requirements for pyrogen and microorganism of water for injection are higher than that of purified water.
The following table lists the differences between pyrogens and microorganisms in purified water and water for injection in the United States Pharmacopoeia.


Category ItemsPurified WaterWater for Injection
Microorganism< 100CFU/mL10CFU/100mL
PyrogenDo Not Specify<0.25EU/mL
Production MethodDistillation / Ion Exchange / Reverse Osmosis / Other Appropriate MethodsDistillation / Reverse Osmosis


  The difference between purified water and water for injection also lies in the water preparation process. There are various options for the preparation process of purified water, but there are restrictions on the preparation process of water for injection in the pharmacopoeia of various countries. For example, the United States Pharmacopoeia clearly stipulates that the preparation process of water for injection can only be distillation and reverse osmosis, while the Chinese Pharmacopoeia stipulates that the production process of water for injection must be distillation. These are the necessary conditions for each country to ensure the quality of water for injection according to its actual situation.
Scope of Application
  1. Sterile and heat free purified water for pharmaceutical, medical and biological industries (purified water in Chinese Pharmacopoeia, U.S. FDA, European Union and Japan)
  2. Production water for medical infusion, pharmaceutical preparations, biological preparations, genetic engineering, renal dialysis, etc   3. Medical device cleaning water
Technological Process
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