Packaging and storage— Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass. The container may be designed to empty rapidly and may contain a volume of more than 1 L.

Labeling— The designation “not for injection” appears prominently on the label.

USP Reference standards 11— USP Endotoxin RS.

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

Sterility 71: meets the requirements.

Residual solvents 467: meets the requirements.

Other requirements— It responds to the Identification tests, and meets the requirements for pH, Heavy metals, Assay for calcium, Assay for potassium, Assay for sodium, and Assay for chloride under Ringer's Injection.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 1931

Phone Number : 1-301-816-8143