Secobarbital Sodium for Injection
»Secobarbital Sodium for Injection is Secobarbital Sodium suitable for parenteral use.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of secobarbital sodium (C12H17N2NaO3).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.9USP Endotoxin Unit per mg of secobarbital sodium.
Other requirements— It conforms to the Definition,responds to the Identificationtests,and meets the requirements for pH,Completeness of solution,Loss on drying,Heavy metals,and Assayunder Secobarbital Sodium.It meets also the requirements for Sterility Tests á71ñ,Uniformity of Dosage Units á905ñ,and Labelingunder Injections á1ñ.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1761
Phone Number:1-301-816-8330
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