Water For Injection Usp Requirements

Ils s usp water for injection quality water is meticulously quality controlled offering the perfect solution for manufacturing uses like formulating processing rinsing and diluting.

Water for injection usp requirements. It is intended to be used as a diluent in the preparation of parenteral products most typically for multi dose products that require repeated. Compendial waters meet the usp ep european pharmacopoeia and jp japan pharmacopoeia requirements but in according with fda the ispe document notes that. That is why an oos investigation must be undertaken if those action levels are exceeded. Many of these waters are usedwater for injection water for injection see the usp.

Additional specifications may be added. The safety of the plastic has been confirmed by tests in animals according to usp biological standards for plastic containers. 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. Ankur choudhary print question forum 4 comments sr no.

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. Specification for water for injection wfi as per usp know the specification of water for injection wfi as per united states pharmacopoeia. Water for injection usp is chemically designated h 2o. For descriptive purposes only.

These are all bulk waters with names given where the pure bulk form of the water is indicated. The semi rigid vial is fabricated from a specially formulated polyolefin. Clear colorless and odorless liquid. 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.

The specifications outlined in the monographs usp ep end jp are the minimum requirements for water for injection and compendial waters. There are also other types of water for which there are noused in manufacturing clinical or analytical applications monographs. The container requires no vapor barrier to. Ils meets the united states pharmacopoeia usp standards for sterile water for injection.

Note water for injection is intended for use in the preparation of parenteral solutions.