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

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.

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

Sterility 71: meets the requirements.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (AER05) Aerosols05

USP29–NF24 Page 807

Phone Number : 1-301-816-8269