Ephedrine Sulfate Oral Solution
» Ephedrine Sulfate Oral Solution contains, in each 100 mL, not less than 360 mg and not more than 440 mg of ephedrine sulfate [(C10H15NO)2·H2SO4].
Packaging and storage Preserve in tight, light-resistant containers, and avoid exposure to excessive heat.
USP Reference standards 11
Identification, Angular rotation 781A Use the 0.1 N sulfuric acid extract of the chloroform solution obtained as directed for Assay preparation: the angular rotation is levorotatory.
Alcohol content 611: between 2.0% and 4.0% of C2H5OH.
Standard preparation Dissolve an accurately weighed quantity of USP Ephedrine Sulfate RS in 0.1 N sulfuric acid to obtain a solution having a known concentration of about 20 µg per mL.
Assay preparation Transfer 5 mL of Oral Solution to a separator, add 1 mL of 1 N sulfuric acid, and extract with 10 mL of chloroform. Discard the extract, and add 5 mL of potassium carbonate solution (1 in 5). After gas evolution has ceased, extract the solution with three 10-mL portions of chloroform, and combine the extracts in a second separator. Extract the chloroform solution with 50.0 mL of 0.1 N sulfuric acid. Filter the acid layer through paper, and dilute 5.0 mL of it with 0.1 N sulfuric acid to 100.0 mL.
Procedure Proceed as directed for Procedure in the Assay under Ephedrine Sulfate Capsules. Calculate the quantity, in mg, of ephedrine sulfate [(C10H15NO)2·H2SO4] in the portion of Oral Solution taken by the formula:
C(AU / AS)in which C is the concentration, in µg per mL, of USP Ephedrine Sulfate RS in the Standard preparation; and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3052Pharmacopeial Forum: Volume No. 30(2) Page 482