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

USP Reference standards 11— USP Endotoxin RS.

Identification— Evaporate 100 mL to about 10 mL: the resulting solution responds to the tests for Acetate 191.

Bacterial endotoxins 85— It contains not more than 0.5 Endotoxin Unit per mL.

pH 791: between 2.8 and 3.4.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements under Injections 1, except that the container in which it is packaged may be designed to empty rapidly and may exceed 1000 mL in capacity.

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

Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals

USP29–NF24 Page 47

Phone Number : 1-301-816-8320