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.
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.
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 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of the upper layer of a freshly prepared mixture of butyl alcohol, water, and formic acid (50:25:7) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by examination under short-wavelength UV light: the RF value of the principal spot obtained from the Inhalation Solution corresponds to that obtained from the Standard solution.
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 71: meets the requirements.
pH 791: between 2.8 and 4.0.
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.
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USP35NF30 Page 3827Pharmacopeial Forum: Volume No. 28(6) Page 1746