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

USP Reference standards á11ñ— USP Amobarbital 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 0.4USP Endotoxin Unit per mg of amobarbital sodium.

Loss on drying á731ñ— Dry about 1g,accurately weighed,at 105for 4hours:it loses not more than 1.0%of its weight.

Other requirements— It conforms to the Definition,responds to the Identificationtests,and meets the requirements for Completeness of solution,pH,Heavy metals,and Assayunder Amobarbital 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 140

Phone Number:1-301-816-8330