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.
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 sulfate, to a 100-mL volumetric flask, add 50.0 mL of 0.30 N acetic acid, dilute with water 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)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.
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Topic/Question Contact Expert Committee
Monograph Kahkashan Zaidi, Ph.D.
Senior Scientist
(AER05) Aerosols05
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2710
Pharmacopeial Forum: Volume No. 28(6) Page 1746