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Endotoxin Test for Purified Water

Updated: 27 March 2019

Is there any requirement to test purified water for endotoxins for risk analysis framework? There is no need to test purified water for endotoxins according to pharmacopoeial monographs. However, if it will be utilized as feed water for distillation and pure steam generators to produce pure steam or Water for injection, it can be utilize to test endotoxins during process of qualification.

Only 3-6 log reduction level of endotoxins is achieved during the generation of pure steam or distillation based on manufacturer or technology. The effectiveness of purification process should be demonstrated to validate water system. Therefore, it is also applicable to all quality attributes such as level of endotoxins in Water for Injection.

Purified water is also applicable in biotechnology sector where the endotoxins level monitoring is significant. Therefore, level of endotoxins in purified water must be tested if being used in biotech sector.

The decision whether to test purified water for endotoxins or not completely depends on where the purified water is being used and which products or applications are critical to have endotoxins.