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.
Assay
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 [(C
10H
15NO)
2·H
2SO
4] 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.