Cupric Chloride Injection
» Cupric Chloride Injection is a sterile solution of Cupric Chloride 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).
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.
USP Reference standards 11
USP Endotoxin RS
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.
Bacterial endotoxins 85 It contains not more than 250.0 USP Endotoxin Units per mg of copper.
pH 791: between 1.5 and 2.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections 1.
Sodium chloride solution— Dissolve 2.7 g of sodium chloride in water, dilute with water to 2000 mL, and mix.
Copper stock solution— Transfer 1.000 g of copper to a 1000-mL volumetric flask, dissolve in 20 mL of nitric acid, dilute with 0.2 N nitric acid to volume, and mix. This solution contains 1000 µg of copper per mL. Store in a polyethylene bottle.
Standard preparations— Pipet 15 mL of Copper stock solution into a 250-mL volumetric flask, dilute with water to volume, and mix. Transfer 4.0, 5.0, and 6.0 mL of this solution to separate 100-mL volumetric flasks containing 10 mL of Sodium chloride solution, dilute the contents of each flask with water to volume, and mix. These Standard preparations contain, respectively, 2.4, 3.0, and 3.6 µg of copper per mL.
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.
Procedure— Concomitantly determine the absorbances of the Standard preparations and the Assay preparation at the copper emission line of 324.8 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering 851) equipped with a copper hollow-cathode lamp and an air–acetylene flame using a 1 in 10 dilution of Sodium chloride solution as the blank. Plot the absorbances of the Standard preparations versus concentration, in µg per mL, of copper, and draw the straight line best fitting the three plotted points. From the graph so obtained, determine the concentration, in µg per mL, of copper in the Assay preparation. Calculate the quantity, in mg, of copper in each mL of the Injection taken by the formula:
2C / 3V
in which C is the concentration, in µg per mL, of copper in the Assay preparation; and V is the volume, in mL, of Injection taken.
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