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 theTest solution,proceed as directed forColor and clarityunderEpinephrine Injection.

Identification— It meets the requirements for theIdentification test underEpinephrine Nasal Solution.

Sterility á71ñ: meets the requirements.

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

Expert Committee:(AER)Aerosols

USP28–NF23Page 740

Phone Number:1-301-816-8269