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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.
Identification— Tablets respond to the Identification test under Oxprenolol Hydrochloride Tablets.
Drug release 724—
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 of 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 of 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. [NOTE—Replace the aliquots withdrawn for analysis with fresh portions of Dissolution medium.]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 1:
Time (hours) Amount dissolved
1, in Acid medium between 15% and 45%
1, in Dissolution medium between 30% and 60%
3, in Dissolution medium between 50% and 80%
7, in Dissolution medium not less than 75%
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. [NOTE—Replace 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.
Time (hours) Amount dissolved
1, in Acid medium between 15% and 45%
1, in Dissolution medium between 30% and 60%
3, in Dissolution medium between 50% and 80%
7, in Dissolution medium not less than 75%
(Official April 1, 2006)
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 Tablets.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Determine the mean value of the C15H23NO3·HCl contents of the Tablets tested as directed under Uniformity of dosage units.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (MDCV05) Monograph Development-Cardiovascular
USP29–NF24 Page 1598
Pharmacopeial Forum : Volume No. 31(1) Page 173
Phone Number : 1-301-816-8305