Isoetharine Inhalation Solution
»Isoetharine Inhalation Solution is a sterile solution of Isoetharine Hydrochloride in Purified Water.It may contain Sodium Chloride.It contains not less than 92.0percent and not more than 108.0percent of the labeled amount of isoetharine hydrochloride (C13H21NO3·HCl).
Packaging and storage— Preserve in small,tight containers that are well-filled or otherwise protected from oxidation.Protect from light.
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—
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— Dilute the Inhalation Solution with water to obtain a solution containing about 2.5mg of isoetharine hydrochloride per mL.Apply 10-µLportions of this solution and a solution of USP Isoetharine Hydrochloride RScontaining 2.5mg per mLto a thin-layer chromatographic plate coated with silica gel mixture.Develop the plate in a mixture consisting ofn-butyl alcohol,water,and formic acid (70:20:10)to a height of 12to 14cm above the point of application.Remove the plate,and evaporate the solvents with the aid of warm,circulating air.Examine under short-wavelength UVlight.Spray the plate with Folin–Ciocalteu phenol TS,and then expose to ammonia vapor until the isoetharine spots develop an intense blue color:theRFvalue and color of the principal spot obtained from the solution under test correspond to those obtained from theStandard solution.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 2.5and 5.5.
Assay—
Standard preparation— Prepare as directed in theAssay underIsoetharine Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Inhalation Solution,equivalent to about 50mg of isoetharine hydrochloride,to a 100-mLvolumetric flask,dilute with 0.17Nacetic acid solution to volume,and mix.
Chromatographic system— Proceed as directed in theAssay underIsoetharine Hydrochloride.
Procedure— Proceed as directed forProcedure in theAssay underIsoetharine Hydrochloride.Calculate the quantity,in mg,of C13H21NO3·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 1066
Pharmacopeial Forum:Volume No.28(6)Page 1745
Phone Number:1-301-816-8269
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