Usp Purified Water Vs Wfi

Sterile water for injection see the usp monograph is water for.

Usp purified water vs wfi.

As previously discussed because of the volume of water actually tested 1ml for endotoxins vs. That is why an oos investigation must be undertaken if those action levels are exceeded. Water for injection is water purified by distillation or reverse osmosis. 100ml for wfi the microbiological test offers a good index of the level of contamination in a system.

Control of the chemical purity of these waters is important and is the main purpose of the monographs in this compendium. Purified water and sterile purified water may be obtained by any suitable process. From usp 1231 water for pharmaceutical purposes. The type of water for pharmaceutical use is determined by usp testing.

The procedure described below is designed for measuring the conductivity of purified water and water for injection. Specification as per usp. Distilled water water for injection sterile distilled water sterile wfi. 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.

Regulatory agencies have required that packaged pw and wfi be tested by the producer using toc and conductivity prior to packaging. 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. 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. 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.

Pharmaceutical technology is the independent source for information insight and analysis on bio pharmaceutical formulation development and manufacturing. Difference between purified water and water for injection.