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 90.0 percent and not more than 115.0 percent 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.
USP Reference standards 11
USP Isoproterenol Hydrochloride RS.
Color and clarity
Using the Inhalation Solution as the Test solution, proceed as directed for Color and clarity under Isoproterenol Inhalation Solution.
Identification
It meets the requirements for Identification tests C, D, and E under Isoproterenol Sulfate.
Sterility 71:
meets the requirements.
Assay
Assay preparation
Transfer an accurately measured volume of Inhalation Solution, equivalent to about 25 mg of isoproterenol sulfate, to a 100-mL volumetric flask, add 50.0 mL of 0.30 N acetic acid, dilute with water to volume, and mix.
Procedure
Proceed as directed for Procedure in the Assay under Isoproterenol Hydrochloride. Calculate the quantity, in mg, of (C11H17NO3)2·H2SO4 in each mL of the Inhalation Solution taken by the formula:
(260.30/247.72)(0.1)(C/V)(hU / hS)
in which 260.30 is one-half of the molecular weight of anhydrous isoproterenol sulfate; 247.72 is the molecular weight of isoproterenol hydrochloride; V is the volume, in mL, of Inhalation Solution taken; and C, hU, and hS are as defined therein.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 2710
Pharmacopeial Forum: Volume No. 28(6) Page 1746
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