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.
USP Reference standards 
11
—
11—
USP Oxprenolol Hydrochloride RS 
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Identification—
Tablets respond to the Identification test under Oxprenolol Hydrochloride Tablets.
Dissolution 711—
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 [note—Replace the aliquots withdrawn for analysis with fresh portions of Dissolution medium.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% |
Uniformity of dosage units 905:
meet the requirements.
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—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Sujatha Ramakrishna, Ph.D.
Senior Scientific Liaison 1-301-816-8349 |
(SM22010) Monographs - Small Molecules 2 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
USP35–NF30 Page 4161
Pharmacopeial Forum: Volume No. 31(1) Page 173