Water For Injection Usp Requirements

Compendial waters meet the usp ep european pharmacopoeia and jp japan pharmacopoeia requirements but in according with fda the ispe document notes that.

Water for injection usp requirements.

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. The semi rigid vial is fabricated from a specially formulated polyolefin. There are also other types of water for which there are noused in manufacturing clinical or analytical applications monographs. Ankur choudhary print question forum 4 comments sr no.

Water for injection usp is chemically designated h 2o. These are all bulk waters with names given where the pure bulk form of the water is indicated. It is intended to be used as a diluent in the preparation of parenteral products most typically for multi dose products that require repeated. It is a copolymer of ethylene and propylene.

Many of these waters are usedwater for injection water for injection see the usp. Clear colorless and odorless liquid. The specifications outlined in the monographs usp ep end jp are the minimum requirements for water for injection and compendial waters. 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. 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. The container requires no vapor barrier to. The safety of the plastic has been confirmed by tests in animals according to usp biological standards for plastic containers.

For descriptive purposes only. That is why an oos investigation must be undertaken if those action levels are exceeded. Specification for water for injection wfi as per usp know the specification of water for injection wfi as per united states pharmacopoeia. Ils meets the united states pharmacopoeia usp standards for sterile water for injection.

Additional specifications may be added.