Edrophonium Chloride Injection
»Edrophonium Chloride Injection is a sterile solution of Edrophonium Chloride in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of C10H16ClNO.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Labeling— Label the Injection in multiple-dose containers to indicate an expiration date of not later than 3years after the date of manufacture,and label the Injection in single-dose containers to indicate an expiration date of not later than 4years after the date of manufacture.
Identification—
A: Ultraviolet Absorption á197Uñ—Test solution versus standard solution prepared as directed in the Assay.
B: Place in a small separator a volume of Injection,equivalent to about 30mg of edrophonium chloride,add 15mLof pH9.6alkaline borate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions)and 5mLof a 1in 1000solution of thymol blue in pH9.6alkaline borate buffer,and mix.Add 10mLof chloroform,shake thoroughly,and allow to settle:a yellow color is produced in the chloroform layer.
C: It responds to the tests for Chloride á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 8.33USP Endotoxin Units per mg of edrophonium chloride.
pHá791ñ: between 5.0and 5.8.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Pipet a volume of Injection,equivalent to about 50mg of edrophonium chloride,into a glass-stoppered,50-mLcentrifuge tube.Add 5mLof pH8.0phosphate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions)and 5g of sodium chloride.Wash the solution with four 20-mLportions of a mixture of equal volumes of solvent hexane and ether.Transfer the aqueous phase to a 100-mLvolumetric flask,add 0.1Nhydrochloric acid to volume,and mix.Transfer a 5-mLaliquot of this solution to a 50-mLvolumetric flask,add 0.1Nhydrochloric acid to volume,and mix test solution.Dissolve an accurately weighed quantity of USP Edrophonium Chloride RSin 0.1Nhydrochloric acid,and dilute quantitatively and stepwise with the acid to obtain a Standard solution having a known concentration of about 50µg per mL.Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 273nm,with a suitable spectrophotometer,using 0.1Nhydrochloric acid as the blank.Calculate the quantity,in mg,of C10H16ClNOin each mLof the Injection taken by the formula:
(C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Edrophonium Chloride RSin the Standard solution;Vis the volume,in mL,of Injection taken;and AUand ASare the absorbances of the test solution and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 715
Phone Number:1-301-816-8251
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