Cupric Chloride Injection
»Cupric Chloride Injection is a sterile solution of Cupric Chloride 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 1.5and 2.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Sodium chloride solution— Dissolve 2.7g of sodium chloride in water,dilute with water to 2000mL,and mix.
Copper stock solution— Transfer 1.000g of copper to a 1000-mLvolumetric flask,dissolve in 20mLof nitric acid,dilute with 0.2Nnitric acid to volume,and mix.This solution contains 1000µg of copper per mL.Store in a polyethylene bottle.
Standard preparations— Pipet 15mLof Copper stock solutioninto a 250-mLvolumetric flask,dilute with water to volume,and mix.Transfer 4.0,5.0,and 6.0mLof this solution to separate 100-mLvolumetric flasks containing 10mLof Sodium chloride solution,dilute the contents of each flask with water to volume,and mix.These Standard preparationscontain,respectively,2.4,3.0,and 3.6µg of copper per mL.
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— Concomitantly determine the absorbances of the Standard preparationsand the Assay preparationat the copper emission line of 324.8nm,with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering á851ñ)equipped with a copper hollow-cathode lamp and an air–acetylene flame using a 1in 10dilution of Sodium chloride solutionas the blank.Plot the absorbances of the Standard preparationsversus 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 mLof the Injection taken by the formula:
2C/3V,
in which Cis the concentration,in µg per mL,of copper in the Assay preparation;and Vis the volume,in mL,of Injection taken.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 553
Phone Number:1-301-816-8394