Specification as per usp.
Usp purified water vs wfi.
Distilled water water for injection sterile distilled water sterile wfi.
The procedure described below is designed for measuring the conductivity of purified water and water for injection.
Stage 1 of the procedure below may alternatively be performed with the appropriate modifications to step 1 using on line instrumentation that has been appropriately calibrated whose cell constants have been accurately determined and whose temperature compensation function has.
From usp 1231 water for pharmaceutical purposes.
The united states pharmacopeia usp defines this as a highly purified water containing less than 10 cfu 100 ml of aerobic bacteria.
Wfi has stricter bacteria controls than purified water and hence the usp mandates these waters should have less than 500 ppb of total organic carbon fewer than 0 25 eu ml endotoxins and a conductivity of less than 1 3 us cm 25 c.
Sterile water for injection see the usp monograph is water for.
Conductivity 1 3 µ s cm at 25 0 c 1 3 µ s cm at 25 0 c total organic carbon toc 500 ppm 500 ppm microbial recommended action limit 100cfu ml 10cfu 100ml endotoxin.
Water for injection is water purified by distillation or reverse osmosis.
As previously discussed because of the volume of water actually tested 1ml for endotoxins vs.
Regulatory agencies have required that packaged pw and wfi be tested by the producer using toc and conductivity prior to packaging.
Difference between purified water and water for injection.
Action levels in usp 1231 100cfu ml for purified water and 10cfu 100ml for water for injection are generally considered to represent a level above which the water is unfit for use.
Unlike other official articles the bulk water monographs purified water and water for injection also limit how the article can be produced because of the belief that the nature and robustness of the purification process is directly related to the resulting purity.
The usp purified water and the usp wfi on the other hand are components or ingredient materials as they are termed by the usp intended to be used in the production of drug products.
That is why an oos investigation must be undertaken if those action levels are exceeded.
Pharmaceutical technology is the independent source for information insight and analysis on bio pharmaceutical formulation development and manufacturing.
100ml for wfi the microbiological test offers a good index of the level of contamination in a system.
