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 90.0 percent and not more than 115.0 percent 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.
USP Reference standards 11
Color and clarity
Standard solution Transfer 2.0 mL of 0.100 N iodine VS to a 500-mL volumetric 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 the Test solution, concomitantly determine the absorbances of the Test solution and the Standard solution in 1-cm cells with a suitable spectrophotometer set at 460 nm: the absorbance of the Test solution does not exceed that of the Standard solution.
Identification The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay.
Sterility 71: meets the requirements.
pH 791: between 2.5 and 5.5.
Standard preparation Prepare as directed in the Assay under Isoproterenol Hydrochloride.
Assay preparation Transfer an accurately measured volume of Inhalation Solution, equivalent to about 25 mg of isoproterenol hydrochloride, to a 100-mL volumetric flask, dilute with 0.17 N acetic acid solution to volume, and mix.
Chromatographic system Proceed as directed in the Assay under Isoproterenol Hydrochloride.
Procedure Proceed as directed for Procedure in the Assay under Isoproterenol Hydrochloride. Calculate the quantity, in mg, of C11H17NO3·HCl in each mL of the Inhalation Solution taken by the formula:
0.1(C/V)(hU / hS)in which V is the volume, in mL, of Inhalation Solution taken; and C, hU, and hS are as defined therein.
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USP35NF30 Page 3579Pharmacopeial Forum: Volume No. 28(6) Page 1746