Usp Purified Water Standards

To ensure adherence to certain minimal chemical and microbiological quality standards water used in the production of drug substances or as source or feed water for the preparation of the various types of purified waters must meet the requirements of the national primary drinking water regulations npdwr 40 cfr 141 issued by the u s.

Usp purified water standards.

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. 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. That is why an oos investigation must be undertaken if those action levels are exceeded. Some are general in nature but others relate.

Usp standards for packaged purified water water for injection and sterile purified water usp24 effective 1 1 00 the following are numerical value limits that are commonly used interpretations of the procedures listed on pages 1752 and 1753 under the individual monographs. Purified water packaged in bulk for commercial use elsewhere meets the requirements of all of the tests under sterile purified water except labeling and sterility 71. Usp reference standards 11 usp 1 4 benzoquinone rs. We have established a process purified water charcoal treatment softening uv sanitization and 0 2um filtration while the water quality is better than drinking water but not good enough to fulfill usp ep water specification only conductivity higher than the criteria 2 3us cm others are all within spec.

Including total vial count and. Standard solution unless otherwise directed in the individual monograph dissolve in the reagent water an accurately weighed quantity of usp sucrose rs to obtain a solution having a concentration of about 1 2 mg of sucrose per l 0 50 mg of carbon per liter. Usp purified water suggested processes by which it can be obtained include deionisation ro deionisation polishing distillation filtration etc. Unlike most of the other systems discussed this is a one way and not recirculating system.

Standards that purified water users may need to think about review and update. Environmental protection agency epa or the drinking. 1 3 μs cm at 25 c in line. Figure 11 and figure12 illustrate another purified water system which had some problems.