Oxprenolol Hydrochloride Extended-Release Tablets
» Oxprenolol Hydrochloride Extended-Release Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of oxprenolol hydrochloride (C15H23NO3·HCl).
Packaging and storage
Preserve in well-closed, light-resistant containers.
Dissolution 711
Acid medium:
0.1 N hydrochloric acid; 900 mL.
Dissolution medium:
simulated intestinal fluid TS (without enzyme); 900 mL.
Apparatus 1:
100 rpm.
Times:
1 hour in Acid medium; 1, 3, and 7 hours in Dissolution medium.
Procedure
Determine the amount of C15H23NO3·HCl dissolved from UV absorbances at the wavelength of maximum absorption at about 272 nm on the first solution under test, suitably diluted with Acid medium, in comparison with a Standard solution having a known concentration of USP Oxprenolol Hydrochloride RS in the same medium. Promptly transfer the basket containing the Tablet to Dissolution medium. After 1, 3, and 7 hours, respectively, remove 9.0 mL of the test solution and determine the amount of C15H23NO3·HCl dissolved from UV absorbances at the wavelength of maximum absorption at about 272 nm on the solution under test, suitably diluted with Dissolution medium, in comparison with a Standard solution having a known concentration of USP Oxprenolol Hydrochloride RS in the same medium. [noteReplace the aliquots withdrawn for analysis with fresh portions of Dissolution medium.]
Tolerances
The percentages of the labeled amount of C15H23NO3·HCl dissolved at the times specified conform to Acceptance Table 2.
Uniformity of dosage units 905:
meet the requirements.
Procedure for content uniformity
Proceed as directed for Procedure for the content uniformity in the test for Uniformity of dosage units under Oxprenolol Hydrochloride Tablets.
Assay
Determine the mean value of the C15H23NO3·HCl contents of the Tablets as directed for Uniformity of dosage units under Oxprenolol Hydrochloride Tablets.
Auxiliary Information
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USP32NF27 Page 3157
Pharmacopeial Forum: Volume No. 31(1) Page 173
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