Manganese Chloride Injection
»Manganese Chloride Injection is a sterile solution of Manganese Chloride in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of manganese (Mn).
Packaging and storage— Preserve in single-dose or in 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 279nm when tested as directed for Procedurein the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.45USP Endotoxin Unit per µg of manganese.
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 1.8g of sodium chloride in water,dilute with water to 2000mL,and mix.
Manganese stock solution— Transfer 1.000g of manganese to a 1000-mLvolumetric flask,dissolve in 20mLof nitric acid,dilute with 0.1Nhydrochloric acid to volume,and mix.This solution contains 1000µg of manganese per mL.Store in a polyethylene bottle.
Standard preparations— Pipet 10mLof the Manganese stock solutioninto a 500-mLvolumetric flask,dilute with water to volume,and mix.Transfer 4.0,5.0,and 6.0mL,respectively,of this solution to separate 50-mLvolumetric flasks,containing 10mLof Sodium chloride solution,dilute the contents of each flask with water to volume,and mix.These Standard preparationscontain,respectively,1.6,2.0,and 2.4µg of manganese per mL.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 1mg of manganese,to a 100-mLvolumetric flask,dilute with water to volume,and mix.Pipet 10mLof this solution into a 50-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 chloride content in this flask to 9mg.Dilute with water to volume,and mix.
Procedure— Concomitantly determine the absorbances of the Standard preparationsand the Assay preparationat the manganese emission line of 279nm,with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering á851ñ)equipped with a manganese hollow-cathode lamp and an air–acetylene flame,using a dilution of Sodium chloride solution(1:5)as the blank.Plot the absorbances of the Standard preparationsversus concentration,in µg per mL,of manganese,and draw the straight line best fitting the three plotted points.From the graph so obtained,determine the concentration,in µg per mL,of manganese in the Assay preparation.Calculate the quantity,in mg,of manganese in each mLof the Injection taken by the formula:
0.5C/V,
in which Cis the concentration,in µg per mL,of manganese 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 1181
Phone Number:1-301-816-8379
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