Water For Injection Usp Definition

Water for injection is water of extra high quality without significant contamination.

Water for injection usp definition.

For descriptive purposes only. Containing polypropylene and thermoplastic elastomers free flex. Sterile water for injection is a pharmaceutic aid vehicle and parenteral fluid replenisher after addition of an appropriate solute. Water for injection usp is chemically designated h 2 o.

The designation small volume injection applies to an injection that is packaged in containers labeled as containing 100 ml or less. Injectable drugs whose solvent is water. 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. A non sterile version may be used in manufacturing with.

Many of these waters are usedwater for injection water for injection see the usp. 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. There are also other types of water for which there are noused in manufacturing clinical or analytical applications monographs. 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.

The usp united states pharmacopeia defines this as highly purified waters containing less than 10 cfu 100 ml of aerobic bacteria. 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. It is intended to be used as a diluent in the preparation of parenteral products most typically for multi dose products that require repeated. These are all bulk waters with names given where the pure bulk form of the water is indicated.

It can be given by injection into a vein muscle or under the skin. Water for injection by definition is water that is intended for use in the manufacture of parenteral i e. Before such use other substances generally must be added to make the solution more or less isotonic. 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.

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.