Metaproterenol Sulfate Inhalation Solution
» Metaproterenol Sulfate Inhalation Solution is a sterile solution of Metaproterenol Sulfate in Purified Water. It may contain Sodium Chloride. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of metaproterenol 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.
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
A:
Apply 4 µL of the Inhalation Solution and 4 µL of an aqueous solution of USP Metaproterenol Sulfate RS containing about 50 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography
![]() ![]()
B:
The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for metaproterenol, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
Sterility
![]() ![]()
pH
![]() ![]()
Assay
Mobile phase, Standard preparation, and Chromatographic system
Prepare as directed in the Assay under Metaproterenol Sulfate.
Assay preparation
Transfer an accurately measured volume of Inhalation Solution, equivalent to about 200 mg of metaproterenol sulfate, to a 100-mL volumetric flask, dilute with 0.01 N hydrochloric acid to volume, and mix.
Procedure
Proceed as directed for Procedure in the Assay under Metaproterenol Sulfate. Calculate the quantity, in mg, of metaproterenol sulfate [(C11H17NO3)2·H2SO4] in each mL of the Inhalation Solution taken by the formula:
100(C/V)(rU / rS)
in which V is the volume, in mL, of Inhalation Solution taken; and C, rU, and rS are as defined therein.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 2903
Pharmacopeial Forum: Volume No. 28(6) Page 1746
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
|