Water For Injection Usp Specification

Having water that meets the standards of the american society for testing and materials astm the u s.

Water for injection usp specification.

And a is the cally assessed by test methods that take at least 48 to 72. Water for injection usp is chemically designated h2o. 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 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 specifications outlined in the monographs usp ep end jp are the minimum requirements for water for injection and compendial waters. 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. Specification for water for injection wfi as per usp know the specification of water for injection wfi as per united states pharmacopoeia. Compendial waters meet the usp ep european pharmacopoeia and jp japan pharmacopoeia requirements but in according with fda the ispe document notes that.

The plastic syringe is molded from a specially formulated polypropylene. Replacing the heavy metals attribute was considered unnecessary because a the source water specifications found in the npdwr for individual heavy metals were tighter than the approximate limit of detection of the heavy metals test for usp xxii water for injection and purified water approximately 0 1 ppm b contemporary water system. 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.

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. Microbial specifications are typi absorption refraction and scattering. Additional specifications may be added. Solutions in contact with the plastic container may.

The nccls and astm classify ultrapure water into three different types depending on the purity level of that water.