Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.

USP Reference standards 11— USP Phenobarbital RS. USP Endotoxin RS.

Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.

Bacterial endotoxins 85— It contains not more than 0.8 USP Endotoxin Unit per mg of phenobarbital sodium.

Residual solvents 467: meets the requirements.

Other requirements— It conforms to the Definition, responds to the Identification tests, and meets the requirements for Completeness of solution, pH, Loss on drying, Heavy metals, and Assay under Phenobarbital Sodium. It meets also the requirements for Sterility Tests 71, Uniformity of Dosage Units 905, and Labeling under Injections 1.

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 1702

Phone Number : 1-301-816-8330