Packaging and storage—
Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type II glass.
Labeling—
Label the Injection to indicate that it is to be diluted to the appropriate strength with Sterile Water for Injection or other suitable fluid prior to administration.
Identification—
The
Assay preparation, prepared as directed in the
Assay, exhibits an absorption maximum at about 279 nm when tested as directed for
Procedure in the
Assay.
Other requirements—
It meets the requirements under
Injections
1
.
Assay—
Assay preparation—
Transfer an accurately measured volume of Injection, equivalent to about 1 mg of manganese, to a 100-mL volumetric flask, dilute with water to volume, and mix. Pipet 10 mL of this solution into a 50-mL volumetric flask, dilute with water to volume, and mix.