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.
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 2260
Pharmacopeial Forum: Volume No. 30(2) Page 482