Packaging and storage— Preserve in single-dose glass or plastic containers,of not larger than 1-Lsize.Glass containers are preferably of Type Ior Type IIglass.

Labeling— Label it to indicate that no antimicrobial or other substance has been added,and that it is not suitable for intravascular injection without its first having been made approximately isotonic by the addition of a suitable solute.

USP Reference standards á11ñ— USP Endotoxin RS.

Bacterial endotoxins á85ñ— It contains not more than 0.25USP Endotoxin Unit per mL.

Sterility á71ñ: meets the requirements.

pHá791ñ: between 5.0and 7.0in a solution containing 0.3mLof saturated potassium chloride solution per 100mLof test specimen.

Particulate matter á788ñ: meets the requirements.

Ammonia— For containers having a fill volume of less than 50mL,dilute 50mLof it with 50mLof High-Purity Water(see Reagentsunder Containers á661ñ),and use this dilution as the test solution;where the fill volume is 50mLor more,use 100mLof it as the test solution.To 100mLof the test solution add 2mLof alkaline mercuric-potassium iodide TS:any yellow color produced immediately is not darker than that of a control containing 30µg of added ammonia (furnished by using 1.76mLof 1.0Nammonium hydroxide)in 100mLof High-Purity Water.This corresponds to a limit of 0.6mg per Lfor containers having a fill volume of less than 50mLand 0.3mg per Lwhere the fill volume is 50mLor more.

Calcium— To 100mLadd 2mLof ammonium oxalate TS:no turbidity is produced.

Carbon dioxide— To 25mLadd 25mLof calcium hydroxide TS:the mixture remains clear.

Chloride— To 20mLin a color-comparison tube add 5drops of nitric acid and 1mLof silver nitrate TS,and gently mix:any turbidity formed within 10minutes is not greater than that produced in a similarly treated control consisting of 20mLof High-Purity Water(see Reagentsunder Containers á661ñ)containing 10µg of chloride (0.5mg per L),viewed downward over a dark surface with light entering the tubes from the sides.

Sulfate— To 100mLadd l mLof barium chloride TS:no turbidity is produced.

Oxidizable substances— To 100mLadd 10mLof 2Nsulfuric acid,and heat to boiling.For Sterile Water for Injection in containers having a fill volume of less than 50mL,add 0.4mLof 0.1Npotassium permanganate,and boil for 5minutes;where the fill volume is 50mLor more,add 0.2mLof 0.1Npotassium permanganate,and boil for 5minutes.If a precipitate forms,cool in an ice bath to room temperature,and pass through a sintered-glass filter:the pink color does not completely disappear.

Expert Committee:(PW)Pharmaceutical Waters

USP28–NF23Page 2034

Phone Number:1-301-816-8328