Test 1: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 1.

Medium: water containing 1% sodium lauryl sulfate; 900 mL.

Apparatus 2: 75 rpm.

Time: 60 minutes.

Procedure— Determine the amount of C15H12N2O dissolved from UV absorbances at the wavelength of maximum absorbance at about 288 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 Carbamazepine RS in the same medium. [NOTE—A volume of methanol not exceeding 1% of the final total volume of the Standard solution may be used to dissolve the carbamazepine.]

Tolerances— Not less than 75% (Q) of the labeled amount of C15H12N2O is dissolved in 60 minutes. Use the Acceptance Table 1 under Dissolution 711, with the following exceptions: at S2, no unit is less than Q 5%; at S3, no unit is less than Q 10%; and not more than 2 of the 24 units are less than Q 5%.

Test 4: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 4.

Medium: 0.1 N hydrochloric acid containing 1% sodium lauryl sulfate; 225 mL. Add 2 drops of simethicone to each.

Apparatus 3 (see Drug release 724): 35 dips per minute; use 20-mesh screen on the top of the reciprocating cylinder and a 100-mesh screen on the bottom of the reciprocating cylinder.

Time: 60 minutes.

Procedure— Determine the amount of C15H12N2O dissolved from UV absorbances at the wavelength of maximum absorbance at about 284 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 Carbamazepine RS in the same medium.

Tolerances— Not less than 70% (Q) of the labeled amount of C15H12N2O is dissolved in 60 minutes, the acceptance criteria specified for Test 1 being used.

Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Medium , Apparatus, and Procedure—Proceed as directed for Test 1.

Times and Tolerances—Between 45% and 75% of the labeled amount of C15H12N2O is dissolved in 15 minutes; not less than 75% (Q) of the labeled amount of C15H12N2O is dissolved in 60 minutes. Use Acceptance Table 1 under Drug Release 724, with the following exceptions: at 15 minutes—at L2, no unit is more than 5% outside the stated range; at L3, no unit is more than 10% outside the stated range; and not more than 2 of the 24 units are more than 5% outside the stated range. At 60 minutes—at L2, no unit is less thanQ 5%; at L3, no unit is less than Q 10%; and not more than 2 of the 24 units are less than Q 5%.

Test 3: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 3.

Medium , Apparatus, and Procedure—Proceed as directed for Test 1.

Times and Tolerances—Between 60% and 85% of the labeled amount of C15H12N2O is dissolved in 15 minutes; not less than 75% (Q) of the labeled amount of C15H12N2O is dissolved in 60 minutes. Use Acceptance Table 1 under Drug Release 724, with the following exceptions: at 15 minutes—at L2, no unit is more than 5% outside the stated range; at L3, no unit is more than 10% outside the stated range; and not more than 2 of the 24 units are more than 5% outside the stated range. At 60 minutes—at L2, no unit is less than Q 5%; at L3, no unit is less than Q 10%; and not more than 2 of the 24 units are less than Q 5%.

Test 1— If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 1.

Medium: water containing 1% sodium lauryl sulfate; 900 mL.

Apparatus 2: 75 rpm.

Time: 60 minutes.

Procedure— Determine the amount of C15H12N2O dissolved from UV absorbances at the wavelength of maximum absorbance at about 288 nm on filtered portions of the solution under test, suitably diluted with Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Carbamazepine RS in the same Medium. [NOTE—A volume of methanol not exceeding 1% of the final total volume of the Standard solution may be used to dissolve the carbamazepine.]

Tolerances— Not less than 75% (Q) of the labeled amount of C15H12N2O is dissolved in 60 minutes. Use Acceptance Table 1, with the following exceptions: at S2, no unit is less thanQ 5%; at S3, no unit is less than Q 10%; and not more than 2 of the 24 units are less than Q 5%.

Test 4— If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 4.

Medium: 0.1 N hydrochloric acid containing 1% sodium lauryl sulfate; 225 mL. Add 2 drops of simethicone to each.

Apparatus 3: 35 dips per minute; use 20-mesh screen on the top of the reciprocating cylinder and a 100-mesh screen on the bottom of the reciprocating cylinder.

Time: 60 minutes.

Procedure— Determine the amount of C15H12N2O dissolved from UV absorbances at the wavelength of maximum absorbance at about 284 nm on filtered portions of the solution under test, suitably diluted with Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Carbamazepine RS in the same Medium.

Tolerances— Not less than 70% (Q) of the labeled amount of C15H12N2O is dissolved in 60 minutes, the acceptance criteria specified for Test 1 being used.

Test 2— If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Medium , Apparatus, and Procedure—Proceed as directed for Test 1.

Times and Tolerances: between 45% and 75% of the labeled amount of C15H12N2O is dissolved in 15 minutes; not less than 75% (Q) of the labeled amount of C15H12N2O is dissolved in 60 minutes. Use Acceptance Table 2, with the following exceptions: at 15 minutes—at L2, no unit is more than 5% outside the stated range; at L3, no unit is more than 10% outside the stated range; and not more than 2 of the 24 units are more than 5% outside the stated range. At 60 minutes—at L2, no unit is less than Q 5%; at L3, no unit is less than Q 10%; and not more than 2 of the 24 units are less than Q 5%.

Test 3— If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 3.

Medium , Apparatus, and Procedure—Proceed as directed for Test 1.

Times and Tolerances: between 60% and 85% of the labeled amount of C15H12N2O is dissolved in 15 minutes; not less than 75% (Q) of the labeled amount of C15H12N2O is dissolved in 60 minutes. Use Acceptance Table 2, with the following exceptions: at 15 minutes—at L2, no unit is more than 5% outside the stated range; at L3, no unit is more than 10% outside the stated range; and not more than 2 of the 24 units are more than 5% outside the stated range. At 60 minutes—at L2, no unit is less than Q 5%; at L3, no unit is less than Q 10%; and not more than 2 of the 24 units are less than Q 5%.

500C(rU / rS),