Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life.
Water for injection usp.
Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute.
It is sterile hypotonic nonpyrogenic and contains no bacteriostatic or antimicrobial agents.
Therefore it is contraindicated for intravenous administration without additives.
The flexible container is fabricated from a specially formulated non plasticized film.
It is a diluent or solvent suitable for intravascular injection after first having been made approximately isotonic by the addition of suitable solute.
Where used for the preparation of parenteral solutions subject to final sterilization use suitable means to minimize microbial growth or first render the water for injection sterile and thereafter protect it from microbial contamination.
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.
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.
Bacteriostatic water for injection bacteriostatic water for injection see usp monograph is sterile water for injection to which has been added one or more suitable antimicrobial preservatives.
Solutions in contact with the plastic container may.
Usp bacteriostatic water for injection usp sterile water for irrigation the usp designation means that the water is the subject of an official monograph in the current us pharmacopeia with various.
Note water for injection is intended for use in the preparation of parenteral solutions.
It is intended to be used as a diluent in the preparation of parenteral products most typically for multi dose products that require repeated.
That is why an oos investigation must be undertaken if those action levels are exceeded.
Sterile water for injection usp is a hemolytic agent due to its hypotonicity.
Water for injection usp is chemically designated h2o.
Sterile water for injection usp is a clear colorless odorless liquid.
Water for injection usp is chemically designated h 2 o.
Sterile water for injection is a pharmaceutic aid vehicle and parenteral fluid replenisher after addition of an appropriate solute.
