Packaging and storage
Preserve in single-dose or 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 325 nm when tested as directed for
Procedure in the
Assay.
Other requirements
It meets the requirements under
Injections 1.
Assay
Sodium chloride solution, Copper stock solution, and Standard preparations
Prepare as directed in the
Assay under
Cupric Chloride Injection.
Assay preparation
Transfer an accurately measured volume of Injection, equivalent to about 2 mg of copper, to a 100-mL volumetric flask, dilute with water to volume, and mix. Pipet 15 mL of this solution into a 100-mL volumetric flask. From the labeled amount of sodium chloride, if any, in the Injection, calculate the amount, in mg, of sodium chloride in the initial dilution, and add sufficient Sodium chloride solution to bring the total sodium content of this flask to 13.5 mg. Dilute with water to volume, and mix.