Isoproterenol Sulfate Inhalation Solution
»Isoproterenol Sulfate Inhalation Solution is a sterile solution of Isoproterenol Sulfate in Purified Water.It may contain Sodium Chloride.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of isoproterenol sulfate [(C11H17NO3)2·H2SO4].
Packaging and storage— Store in small,tight containers that are well-filled or otherwise protected from oxidation.Protect from light.
Labeling— Label it to indicate 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 clarity underIsoproterenol Inhalation Solution.
Identification— It meets the requirements forIdentification testsC,D,andEunderIsoproterenol Sulfate.
Sterility á71ñ: meets the requirements.
Assay—
Standard preparation— Prepare as directed in theAssay under Isoproterenol Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Inhalation Solution,equivalent to about 25mg of isoproterenol sulfate,to a 100-mLvolumetric flask,add 50.0mLof 0.30Nacetic acid,dilute with water to volume,and mix.
Chromatographic system— Proceed as directed in theAssay underIsoproterenol Hydrochloride.
Procedure— Proceed as directed forProcedure in theAssay underIsoproterenol Hydrochloride.Calculate the quantity,in mg,of (C11H17NO3)2·H2SO4in each mLof the Inhalation Solution taken by the formula:
(260.30/247.72)(0.1)(C/V)(hU/hS),
in which 260.30is one-half of the molecular weight of anhydrous isoproterenol sulfate;247.72is the molecular weight of isoproterenol hydrochloride;Vis the volume,in mL,of Inhalation Solution taken;andC,hU,andhSare as defined therein.
Auxiliary Information— Staff Liaison:Kahkashan Zaidi,Ph.D.,Senior Scientific Associate
Expert Committee:(AER)Aerosols
USP28–NF23Page 1084
Pharmacopeial Forum:Volume No.28(6)Page 1746
Phone Number:1-301-816-8269