Edrophonium Chloride Injection
» Edrophonium Chloride Injection is a sterile solution of Edrophonium Chloride in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C10H16ClNO.
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
Labeling Label the Injection in multiple-dose containers to indicate an expiration date of not later than 3 years after the date of manufacture, and label the Injection in single-dose containers to indicate an expiration date of not later than 4 years after the date of manufacture.
A: Ultraviolet Absorption 197UTest solution versus standard solution prepared as directed in the Assay.
B: Place in a small separator a volume of Injection, equivalent to about 30 mg of edrophonium chloride, add 15 mL of pH 9.6 alkaline borate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions) and 5 mL of a 1 in 1000 solution of thymol blue in pH 9.6 alkaline borate buffer, and mix. Add 10 mL of chloroform, shake thoroughly, and allow to settle: a yellow color is produced in the chloroform layer.
C: It responds to the tests for Chloride 191.
Bacterial endotoxins 85 It contains not more than 8.33 USP Endotoxin Units per mg of edrophonium chloride.
pH 791: between 5.0 and 5.8.
Other requirements It meets the requirements under Injections 1.
Assay Pipet a volume of Injection, equivalent to about 50 mg of edrophonium chloride, into a glass-stoppered, 50-mL centrifuge tube. Add 5 mL of pH 8.0 phosphate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions) and 5 g of sodium chloride. Wash the solution with four 20-mL portions of a mixture of equal volumes of solvent hexane and ether. Transfer the aqueous phase to a 100-mL volumetric flask, add 0.1 N hydrochloric acid to volume, and mix. Transfer a 5-mL aliquot of this solution to a 50-mL volumetric flask, add 0.1 N hydrochloric acid to volume, and mix test solution. Dissolve an accurately weighed quantity of USP Edrophonium Chloride RS in 0.1 N hydrochloric acid, and dilute quantitatively and stepwise with the acid to obtain a Standard solution having a known concentration of about 50 µg per mL. Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 273 nm, with a suitable spectrophotometer, using 0.1 N hydrochloric acid as the blank. Calculate the quantity, in mg, of C10H16ClNO in each mL of the Injection taken by the formula:
(C / V)(AU / AS)in which C is the concentration, in µg per mL, of USP Edrophonium Chloride RS in the Standard solution; V is the volume, in mL, of Injection taken; and AU and AS are the absorbances of the test solution and the Standard solution, respectively.
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USP32NF27 Page 2231