Cupric Sulfate Injection

Cupric Sulfate Injection is a sterile solution of Cupric Sulfate in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of copper (Cu).

1 Packaging and storage

Preserve in single-dose or multiple-dose containers, preferably of Type I or Type II glass.

2 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.

3 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.

3.1 BACTERIAL ENDOTOXINS TEST (85)

It contains not more than 250.0 USP Endotoxin Units per mg of copper.

3.2 PH (791)

between 2.0 and 3.5.

3.3 PARTICULATE MATTER IN INJECTIONS (788)

meets the requirements for small-volume injections.

4 Other requirements

It meets the requirements under Injections and Implanted Drug Products (1).

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5 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 chloride (ERR 1-Dec-2018) content of this flask to 13.5 mg. Dilute with water to volume, and mix.

Procedure-Proceed as directed for Procedure in the Assay under Cupric Chloride Injection.