Ephedrine Sulfate Oral Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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].

1 Packaging and storage

—Preserve in tight, light-resistant containers, and avoid exposure to excessive heat.

USP Reference standards 〈11〉—

USP Ephedrine Sulfate RS

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 Determination 〈611〉 : between 2.0% and 4.0% of C H OH.

2 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 [(C₁₀H₁₅NO)₂ · H₂SO₄] in the portion of Oral Solution taken by the formula:

C(A_U/A_S)

in which C is the concentration, in μg per mL, of USP Ephedrine Sulfate RS in the Standard preparation; and A and A are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.