Ephedrine Sulfate Syrup
(Current title—not to change until June 1,2005)
Monograph title change—to become official June 1,2005
See Ephedrine Sulfate Oral Solution
»Ephedrine Sulfate Syrup contains,in each 100mL,not less than 360mg and not more than 440mg of (C10H15NO)2·H2SO4.
Packaging and storage— Preserve in tight,light-resistant containers,and avoid exposure to excessive heat.
Change to read:
Identification,Angular rotationá781Añ— UseUSP28the 0.1Nsulfuric acid extract of the chloroform solution obtained as directed for the Assay preparation:the angular rotation is levorotatory.USP28
Alcohol content á611ñ: between 2.0%and 4.0%of C2H5OH.
Assay—
Standard preparation— Dissolve an accurately weighed quantity of USP Ephedrine Sulfate RSin 0.1Nsulfuric acid to obtain a solution having a known concentration of about 20µg per mL.
Assay preparation— Transfer 5mLof Syrup to a separator,add 1mLof 1Nsulfuric acid,and extract with 10mLof chloroform.Discard the extract,and add 5mLof potassium carbonate solution (1in 5).After gas evolution has ceased,extract the solution with three 10-mLportions of chloroform,and combine the extracts in a second separator.Extract the chloroform solution with 50.0mLof 0.1Nsulfuric acid.Filter the acid layer through paper,and dilute 5.0mLof it with 0.1Nsulfuric acid to 100.0mL.
Procedure— Proceed as directed for Procedurein the Assayunder Ephedrine Sulfate Capsules.Calculate the quantity,in mg,of (C10H15NO)2·H2SO4in the portion of Syrup taken by the formula:
C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Ephedrine Sulfate RSin the Standard preparation;and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 739
Pharmacopeial Forum:Volume No.30(2)Page 482
Phone Number:1-301-816-8379