Chromic Chloride Injection
»Chromic Chloride Injection is a sterile solution of Chromic Chloride in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of chromium (Cr).
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 360nm when tested as directed for Procedurein the Assay.
Bacterial endotoxins á85ñ— It contains not more than 16.70USP Endotoxin Units per µg of chromium.
pHá791ñ: between 1.5and 2.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Sodium chloride solution— Dissolve 54g of sodium chloride in water,dilute with water to 2000mL,and mix.
Chromium stock solution— Transfer 2.829g of potassium dichromate,accurately weighed,to a 1000-mLvolumetric flask,dissolve in water,dilute with water to volume,and mix.This solution contains 1000µg of chromium per mL.Store in a polyethylene bottle.
Standard preparations— Pipet 10mLof the Chromium stock solutioninto a 1000-mLvolumetric flask,dilute with water to volume,and mix.Transfer 10.0mLand 20.0mL,respectively,of this stock solution to separate 100-mLvolumetric flasks,and transfer 15.0mLand 20.0mL,respectively,of the stock solution to separate 50-mLvolumetric flasks.Add 20mLof Sodium chloride solutionto each 100-mLvolumetric flask,and 10mLof Sodium chloride solutionto each 50-mLvolumetric flask,dilute the contents of each flask with water to volume,and mix.These Standard preparationscontain,respectively,1.0,2.0,3.0,and 4.0µg of chromium per mL.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 60µg of chromium,to a 25-mLvolumetric flask.From the labeled amount of sodium chloride,if any,in the Injection,calculate the amount,in mg,of sodium chloride in the volume of Injection taken,and add sufficient Sodium chloride solutionto bring the total sodium chloride content of the flask to 135mg.Dilute with water to volume,and mix.
Procedure— Concomitantly determine the absorbances of the Standard preparationsand the Assay preparationat the chromium emission line of 357.9nm,with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering á851ñ)equipped with a chromium hollow-cathode lamp and an air–acetylene flame,using a 1:5dilution of the Sodium chloride solutionas the blank.Plot the absorbances of the Standard preparationsversus concentration,in µg per mL,of chromium,and draw the straight line best fitting the four plotted points.From the graph so obtained,determine the concentration,in µg per mL,of chromium in the Assay preparation.Calculate the quantity,in µg,of chromium in each mLof the Injection taken by the formula:
25C/V,
in which Cis the concentration,in µg per mL,of chromium in the Assay preparation,and Vis the volume,in mL,of Injection taken.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 466
Phone Number:1-301-816-8379