Epinephrine Inhalation Solution
» 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.
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.
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.
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Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Principal Scientific Liaison
(SM42010) Monographs - Small Molecules 4
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 3054
Pharmacopeial Forum: Volume No. 28(6) Page 1744