Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.

USP Reference standards á11ñ— USP Phenobarbital RS.USP Endotoxin RS.

Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.

Bacterial endotoxins á85ñ— It contains not more than 0.8USP Endotoxin Unit per mg of phenobarbital sodium.

Other requirements— It conforms to the Definition,responds to the Identificationtests,and meets the requirements for Completeness of solution,pH,Loss on drying,Heavy metals,and Assayunder Phenobarbital Sodium.It meets also the requirements for Sterility Tests á71ñ,Uniformity of Dosage Units á905ñ,and Labelingunder Injections á1ñ.

Expert Committee:(PA3)Pharmaceutical Analysis 3

USP28–NF23Page 1532

Phone Number:1-301-816-8330