Cupric Sulfate Injection
»Cupric Sulfate Injection is a sterile solution of Cupric Sulfate in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of copper (Cu).
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Ior Type IIglass.
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 325nm when tested as directed for Procedurein the Assay.
Bacterial endotoxins á85ñ— It contains not more than 250.0USP Endotoxin Units per mg of copper.
pHá791ñ: between 2.0and 3.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Sodium chloride solution,Copper stock solution,and Standard preparations— Prepare as directed in the Assayunder Cupric Chloride Injection.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 2mg of copper,to a 100-mLvolumetric flask,dilute with water to volume,and mix.Pipet 15mLof this solution into a 100-mLvolumetric 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 solutionto bring the total sodium content of this flask to 13.5mg.Dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Cupric Chloride Injection.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 554
Phone Number:1-301-816-8251