That is why an oos investigation must be undertaken if those action levels are exceeded.
Water for injection usp specification.
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.
First supplement to usp 35 nf 30 general information 1231 water for pharmaceutical purposes5219 incident on the sample and includes losses due to solvent nature of this raw material.
The plastic syringe is molded from a specially formulated polypropylene.
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.
Note water for injection is intended for use in the preparation of parenteral solutions.
The nccls and astm classify ultrapure water into three different types depending on the purity level of that water.
Specification for water for injection wfi as per usp know the specification of water for injection wfi as per united states pharmacopoeia.
Pharmacopeia usp and the national committee for clinical laboratory standards nccls is the best way to accomplish this.
Additional specifications may be added.
Water for injection usp is chemically designated h2o.
Having water that meets the standards of the american society for testing and materials astm the u s.
Compendial waters meet the usp ep european pharmacopoeia and jp japan pharmacopoeia requirements but in according with fda the ispe document notes that.
The specifications outlined in the monographs usp ep end jp are the minimum requirements for water for injection and compendial waters.
Solutions in contact with the plastic container may.
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.
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.
Microbial specifications are typi absorption refraction and scattering.