Metaproterenol Sulfate Tablets
» Metaproterenol Sulfate Tablets contain not less than 92.0 percent and not more than 108.0 percent of the labeled amount of metaproterenol sulfate [(C11H17NO3)2·H2SO4].
Packaging and storage
Preserve in well-closed, light-resistant containers.
Identification
A:
Powder a number of Tablets, equivalent to about 100 mg of metaproterenol sulfate, add 10 mL of water, stir for about 3 minutes, and centrifuge. Use the clear solution so obtained as the Test solution. Dissolve a suitable quantity of USP Metaproterenol Sulfate RS in water to obtain a Standard solution having a concentration of 10 mg per mL. Apply separate 10-µL portions of the Test solution and the Standard solution to a thin-layer chromatographic plate (see Chromatography
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B:
Mix a quantity of powdered Tablets, equivalent to about 20 mg of metaproterenol sulfate, with 5 mL of water, and filter: the filtrate responds to the tests for Sulfate
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Dissolution
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Medium:
water; 500 mL.
Apparatus 2:
50 rpm.
Time:
30 minutes.
Procedure
Determine the amount of (C11H17NO3)2·H2SO4 dissolved from UV absorbances at the wavelength of maximum absorbance at about 276 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Metaproterenol Sulfate RS in the same Medium.
Tolerances
Not less than 70% (Q) of the labeled amount of (C11H17NO3)2·H2SO4 is dissolved in 30 minutes.
Uniformity of dosage units
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Assay
Mobile phase, Standard preparation, and Chromatographic system
Prepare as directed in the Assay under Metaproterenol Sulfate.
Assay preparation
Transfer 20 Tablets to a 500-mL conical flask. Add an accurately measured volume of 0.01 N hydrochloric acid sufficient to yield a solution containing about 2 mg of metaproterenol sulfate per mL, shake by mechanical means for 30 minutes, and filter. Use the filtrate so obtained as the Assay preparation.
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 Tablet taken by the formula:
(CV / 20)(rU / rS)
in which V is the volume, in mL, of 0.01 N hydrochloric acid added; 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 2904
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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