Epinephrine Nasal Solution
»Epinephrine Nasal Solution is a solution of Epinephrine in Purified Water prepared with the aid of Hydrochloric Acid.It contains,in each 100mL,not less than 90mg and not more than 115mg of C9H13NO3.
Packaging and storage— Preserve in small,well-filled,tight,light-resistant containers.
Labeling— The label indicates that the Nasal 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 Nasal Solution as the Test solution,proceed as directed for Color and clarityunder Epinephrine Injection.
Identification— To 5mLof pH4.0acid phthalate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions)add 0.5mLof Nasal Solution and 1.0mLof 0.1Niodine.Mix,and allow to stand for 5minutes.Add 2mLof sodium thiosulfate solution (1in 40):a deep red color is produced.
Change to read:
Assay— Pipet 30mLof Nasal Solution into a 125-mLseparator,add 25mLof chloroform,shake vigorously for 1minute,allow the liquids to separate,and discard the chloroform.Wash twice more with chloroform,separating and discarding the lower layer as completely as possible each time.Rinse the stopper and mouth of the separator with a few drops of water.Add 0.2mLof starch TS,then while swirling the separator add iodine and potassium iodide TSdropwise until the blue color formed persists,and immediately add just sufficient 0.1Nsodium thiosulfate to discharge the blue color.[NOTE—Proceed with the assay from this point without delay.]
Add to the liquid in the separator 2.10g of sodium bicarbonate,preventing it from coming in contact with the mouth of the separator,and swirl until most of the bicarbonate has dissolved.By means of a 1-mLsyringe that is not fitted with a needle,rapidly inject 1.0mLof acetic anhydride directly into the contents of the separator.Immediately insert the stopper in the separator,and shake vigorously until the evolution of carbon dioxide has ceased (7to 10minutes),releasing the pressure as necessary through the stopcock.Allow to stand for 5minutes,and extract the solution with six 25-mLportions of chloroform,filtering each extract through a small pledget of cotton,previously washed with chloroform,into a beaker.
Evaporate the combined chloroform extracts on a steam bath in a current of air to about 3mL,transfer the residue by means of small portions of chloroform to a tared 50-mLbeaker,and heat again to evaporate the solvent completely.Heat further at 105for 30minutes,cool in a desiccator,and weigh the residue of triacetylepinephrine.Add 5.0mLof chloroform,cover the beaker,gently swirl the contents until the residue has completely dissolved,and determine the specific rotation,R,using a 200-mm semimicro polarimeter tube.
Calculate the quantity,in mg,of C9H13NO3in the volume of Nasal Solution taken by the formula:
(183.20/309.32)(W)(0.5+0.5R/93),
in which 183.20and 309.32are the molecular weights of epinephrine and triacetylepinephrine,respectively;and Wis the weight,in mg,and Ris the specific rotation (in degrees,without regard to the sign),of the isolated triacetylepinephrine.
Auxiliary Information— Staff Liaison:Kahkashan Zaidi,Ph.D.,Senior Scientific Associate
Expert Committee:(AER)Aerosols
USP28–NF23Page 741
Pharmacopeial Forum:Volume No.30(4)Page 1192
Phone Number:1-301-816-8269