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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 (C
12
H
17
N
2
NaO
3
).
Packaging and storage—
Preserve in
Containers for Sterile Solids
as described under
Injections
1
.
USP Reference standards
11
—
USP Secobarbital 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 0.9 USP Endotoxin Unit per mg of secobarbital sodium.
Residual solvents
467
:
meets the requirements.
(Official January 1, 2007)
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
.
Auxiliary Information—
Staff Liaison
:
Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee
: (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24
Page 1954
Phone Number
: 1-301-816-8330
1
.