Preserve in single dose glass or fied see 8 230.
Usp monograph for purified water.
It contains no added substance.
That is why an oos investigation must be undertaken if those action levels are exceeded.
Where the fill volume is 50 ml or more add 0 2 ml of 0 1 n potassium permanganate and boil for 5 minutes.
The procedure described below is designed for measuring the conductivity of purified water and water for injection.
Water under 8 terms and definitions in the plastic containers of not larger than 1 l size.
Glass containersgeneral notices and requirements where used for sterile dos.
For sterile purified water in containers having a fill volume of less than 50 ml add 0 4 ml of 0 1 n potassium permanganate and boil for 5 minutes.
Usp 35 official monographs water5041 additional requirements preparations and in tests and assays unless otherwise speci packaging and storage.
Purified water is water obtained by a suitable process.
Environmental protection agency national primary drinking water regulations or with the drinking water usp29 regulations of the european union japan or with the world health organization s guidelines for drinking water quality.
1927 1929 and 1231 water for pharmaceutical purposes p.
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 ide.
You may purchase usp24 by calling customer service at 800 877 6733.
1752 1754 and the general chapters 643 toc 645 water conductivity p.
Including total vial count and.
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.
It is prepared from water complying with the u s.
We can not provide photocopies of copyrighted material.
Purified water purified water see usp monograph is used as an excipient in the production of nonparenteral preparations and in other pharmaceutical applications such as cleaning of certain equipment and nonparenteral product contact components.
Usp24 contains complete versions of all pharmaceutical water monographs p.
