Secobarbital Sodium for Injection
» Secobarbital Sodium for Injection is Secobarbital Sodium suitable for parenteral use. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of secobarbital sodium (C12H17N2NaO3).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
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 0.9 USP Endotoxin Unit per mg of secobarbital sodium.
Other requirements— It conforms to the Definition, responds to the Identification tests, and meets the requirements for pH, Completeness of solution, Loss on drying, Heavy metals, and Assay under Secobarbital Sodium. It meets also the requirements for Sterility Tests 71, Uniformity of Dosage Units 905, and Labeling under Injections 1.
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Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
1-301-816-8330
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
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(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3545