Epinephrine Inhalation Solution

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

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

DOWNLOAD PDF HERE

Epinephrine Inhalation Solution is a sterile solution of Epinephrine in Purified Water prepared with the aid of Hydrochloric Acid. It contains, in each 100 mL, not less than 0.9 g and not more than 1.15 g of C₉H₁₃NO₃.

1 Packaging and storage

—Preserve in small, well-filled, tight, light-resistant containers.

2 Labeling

—The label indicates that the Inhalation Solution is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Color and clarity—Using the Inhalation Solution as the Test solution, proceed as directed for Color and clarity under Epinephrine Injection.

3 Identification

—It meets the requirements for the Identification test under Epinephrine Nasal Solution.

Sterility Tests 〈71〉: meets the requirements.

4 Assay

—Pipet 10 mL of Inhalation Solution into a 125-mL separator, and extract the solution with two 10-mL portions of chloroform. Proceed as directed in the Assay under Epinephrine Nasal Solution, beginning with “Rinse the stopper and mouth of the separator,” but use for the acetylation 1.05 g of sodium bicarbonate and 0.50 mL of acetic anhydride, and extract the acetylated product with six 15-mL portions of chloroform instead of the 25-mL portions specified therein, and use 15.0 mL of chloroform instead of 5.0 mL in the determination of the specific rotation.