Isoproterenol Inhalation Solution
»Isoproterenol Inhalation Solution is a sterile solution of Isoproterenol Hydrochloride 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 hydrochloride (C11H17NO3·HCl).
Packaging and storage— Preserve 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—
Standard solution— Transfer 2.0mLof 0.100Niodine VSto a 500-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Visually examine a portion of the Inhalation Solution (Test solution)in a suitable clear glass test tube against a white background:it is not pinkish and it contains no precipitate.If any yellow color is observed in theTest solution,concomitantly determine the absorbances of theTest solution and theStandard solution in 1-cm cells with a suitable spectrophotometer set at 460nm:the absorbance of theTest solution does not exceed that of theStandard solution.
Identification— The retention time of the major peak in the chromatogram of theAssay preparation corresponds to that of theStandard preparation obtained as directed in theAssay.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 2.5and 5.5.
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 hydrochloride,to a 100-mLvolumetric flask,dilute with 0.17Nacetic acid solution to volume,and mix.
Chromatographic system— Proceed as directed in theAssay under Isoproterenol Hydrochloride.
Procedure— Proceed as directed forProcedure in theAssay underIsoproterenol Hydrochloride.Calculate the quantity,in mg,of C11H17NO3·HCl in each mLof the Inhalation Solution taken by the formula:
0.1(C/V)(hU/hS),
in whichVis 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 1078
Pharmacopeial Forum:Volume No.28(6)Page 1746
Phone Number:1-301-816-8269