Water For Injection Usp Definition

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.

Water for injection usp definition. The usp united states pharmacopeia defines this as highly purified waters containing less than 10 cfu 100 ml of aerobic bacteria. These are all bulk waters with names given where the pure bulk form of the water is indicated. 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. Note water for injection is intended for use in the preparation of parenteral solutions.

That is why an oos investigation must be undertaken if those action levels are exceeded. The flexible container is fabricated from a specially formulated non plasticized film. A sterile version is used for making solutions that will be given by injection. It is intended to be used as a diluent in the preparation of parenteral products most typically for multi dose products that require repeated.

Many of these waters are usedwater for injection water for injection see the usp. Sterile water for injection is a pharmaceutic aid vehicle and parenteral fluid replenisher after addition of an appropriate solute. 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. Before such use other substances generally must be added to make the solution more or less isotonic.

Water for injection usp is chemically designated h 2 o. There are also other types of water for which there are noused in manufacturing clinical or analytical applications monographs. Water for injection by definition is water that is intended for use in the manufacture of parenteral i e. It can be given by injection into a vein muscle or under the skin.

Injectable drugs whose solvent is water. For descriptive purposes only. Water for injection is water of extra high quality without significant contamination. Biologics the pharmacopeial definitions for sterile preparations for parenteral use generally do not apply in the case of the biologics because of their special nature and licensing requirements see biologics 1041.

Containing polypropylene and thermoplastic elastomers free flex. The designation small volume injection applies to an injection that is packaged in containers labeled as containing 100 ml or less.