Packaging and storage— Preserve in single-dose containers,preferably of Type Ior Type IIglass,and store at controlled room temperature.It may be packaged in suitable plastic containers.

USP Reference standards á11ñ— USP Endotoxin RS.

Identification— Evaporate 100mLto about 10mL:the resulting solution responds to the tests for Acetate á191ñ.

Bacterial endotoxins á85ñ— It contains not more than 0.5Endotoxin Unit per mL.

pHá791ñ: between 2.8and 3.4.

Other requirements— It meets the requirements under Injections á1ñ,except that the container in which it is packaged may be designed to empty rapidly and may exceed 1000mLin capacity.

Assay— Pipet 50mLof Irrigation into a 150-mLconical flask,add 2drops of phenolphthalein TS,and titrate with 0.1Nsodium hydroxide VS.Each mLof 0.1Nsodium hydroxide is equivalent to 6.005mg of C2H4O2.

Expert Committee:(PA6)Pharmaceutical Analysis 6

USP28–NF23Page 43

Phone Number:1-301-816-8389