Environmental sterility tests 71.
Usp purified water definition.
Purified water is water that has been filtered or processed to remove impurities like chemicals and other contaminants.
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.
However it must pass the usp shelf life standards which are detailed in the folowing tables.
It is the maintainence of the water production system that is of concern to those in water treatment.
Distilled water has been the most common form of purified water but in recent years water is more frequently purified by other processes including capacitive deionization reverse osmosis carbon filtering microfiltration ultrafiltration ultraviolet oxidation or.
That is why an oos investigation must be undertaken if those action levels are exceeded.
Definition water conductivity sterile water 645.
Unless otherwise specified purified water is also to be used for all tests and assays for which water is indicated see general notices and requirements.
The united states pharmacopoeia usp has three general specifications for water quality that are applicable to medical and pharmaceutical uses namely usp water for injection wfi usp purified water and drinking water 81.
Purified water is water that has been mechanically filtered or processed to remove impurities and make it suitable for use.
It is usually produced using groundwater or tap water.
Purified water is also referenced throughout the usp nf.
Meets the purified water is water obtained by a suitable process.
It is pre requirements pared from water complying with the u.
5220 1231 water for pharmaceutical purposes general information first supplement to usp 35 nf 30 dbp levels in drinking water can be minimized by using purified water purified water see the usp monograph disinfectants such as ozone chloramines or chlorine diox is used as an excipient in the production of nonparenteral.
Regardless of the font and letter case used in its spelling water complying with the purified water monograph is intended.
The primary difference between wfi and pw is the tolerance of microorganismas and endotoxins.
Meets the requirements protection agency national primary drinking water regula additional requirements.
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.
