<701> DISINTEGRATION

Apparatus Basket-Rack Assembly Disks

<711> DISSOLUTION

All dosage forms Immediate-release dosage forms Extended-release dosage forms Delayed-release dosage forms

Apparatus 1 (Basket Apparatus) Apparatus 2 (Paddle Apparatus) Apparatus 3 (Reciprocating Cylinder) Apparatus 4 (Flow-Through Cell)

DISSOLUTION

Acceptance Table : Immediate-Release Dosage Forms Stage Number Tested Acceptance Criteria S1 6 Each unit is not less than Q + 5%. S2 Average of 12 units (S1 + S2) is equal to or greater than Q, and no unit is less than Q- 15%. S3 12 Average of 24 units (S1 + S2 +S3) is equal to or greater than Q, not more than 2 units are less than Q- 15%, and no unit is less than Q- 25%.

Acceptance Table: Immediate-Release Dosage Forms Pooled Sample Stage Number Tested Acceptance Criteria S1 6 Average amount dissolved is not less than Q + 10%. S2 Average amount dissolved (S1 + S2) is equal to or greater than Q + 5%. S3 12 Average amount dissolved (S1 + S2 + S3) is equal to or greater than Q.

Acceptance Table: Delayed-Release Dosage Forms - Acid Stage Level Number Tested Criteria A1 6 No individual value exceeds 10% dissolved. A2 Average of the 12 units (A1 +A2) is not more than 10% dissolved, and no individual unit is greater than 25% dissolved. A3 12 Average of the 24 units (A1 + A2 +A3) is not more than 10% dissolved, and no individual unit is greater than 25% dissolved.

Acceptance Table: Delayed-Release Dosage Forms - Buffer Stage Level Number Tested Criteria B1 6 Each unit is not less than Q + 5%. B2 Average of 12 units (B1 + B2) is equal to or greater than Q, and no unit is less than Q – 15%. B3 12 Average of 24 units (B1 + B2 + B3) is equal to or greater than Q, not more than 2 units are less than Q – 15%, and no unit is less than Q – 25%.

Acceptance Table : Extended-Release Dosage Forms Level Number Tested Criteria L1 6 No individual value lies outside each of the stated ranges and no individual value is less than the stated amount at the final test time. L2 The average value of the 12 units (L1 + L2) lies within each of the stated ranges and is not less than the stated amount at the final test time; none is more than 10% of labeled content outside each of the stated ranges; and none is more than 10% of labeled content below the stated amount at the final test time. L3 12 The average value of the 24 units (L1 + L2 + L3) lies within each of the stated ranges, and is not less than the stated amount at the final test time; not more than 2 of the 24 units are more than 10% of labeled content outside each of the stated ranges; not more than 2 of the 24 units are more than 10% of labeled content below the stated amount at the final test time; and none of the units is more than 20% of labeled content outside each of the stated ranges or more than 20% of labeled content below the stated amount at the final test time.

Acetaminophen Extended-Release Tablets Dissolution 711— test 1— Medium: simulated gastric fluid TS (without enzyme); 900 mL. Apparatus 2: 50 rpm. Times: 15 minutes, 1 hour, and 3 hours. Procedure— Determine the amount of C8H9NO2 dissolved from UV absorbances at 280 nm, using a filtered portion of the solution under test in comparison with a Standard solution having a known concentration of USP Acetaminophen RS in the same Medium. Tolerances— The percentages of the labeled amount of C8H9NO2 dissolved at the times specified conform to Acceptance Table 2. Time Amount dissolved 15 minutes between 45% and 65% 1 hour between 60% and 85% 3 hours not less than 85%

Propranolol Hydrochloride Extended-Release Capsules Dissolution 711— test 1— If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 1. pH 1.2 Buffer solution— Dissolve 2.0 g of sodium chloride in water, add 7.0 mL of hydrochloric acid, dilute with water to 1 L, and mix. pH 6.8 Buffer solution— Dissolve 21.72 g of anhydrous dibasic sodium phosphate and 4.94 g of citric acid monohydrate in water, dilute with water to 1 L, and mix. Media— Proceed as directed under Method B for Delayed-Release Dosage Forms, using 900 mL of pH 1.2 Buffer solution during the Acid stage, run for 1.5 hours, and use the acceptance criteria given under Acceptance Table 3. For the Buffer stage, use 900 mL of pH 6.8 Buffer solution, run for the time specified, and use the acceptance criteria given under Tolerances. Apparatus 1: 100 rpm. Times: 1.5, 4, 8, 14, and 24 hours. Procedure— Using filtered portions of the solution under test, diluted if necessary, determine the amount of C16H21NO2·HCl dissolved, using UV absorbances at the wavelength of maximum absorbance at about 320 nm, with respect to a baseline drawn from 355 nm through 340 nm, by comparison with a Standard solution in water having a known concentration of USP Propranolol Hydrochloride RS. Tolerances— The percentages of the labeled amount of C16H21NO2·HCl dissolved at the times specified conform to Acceptance Table 2. Time (hours) Amount dissolved 1.5 not more than 30% 4 between 35% and 60% 8 between 55% and 80% 14 between 70% and 95% 24 between 81% and 110%

Acetaminophen Tablets Dissolution 711— Medium: pH 5.8 phosphate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions); 900 mL. Apparatus 2: 50 rpm. Time: 30 minutes. Procedure— Determine the amount of C8H9NO2 dissolved by employing UV absorption at the wavelength of maximum absorbance at about 243 nm on 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 Acetaminophen RS in the same Medium. Tolerances— Not less than 80% (Q) of the labeled amount of C8H9NO2 is dissolved in 30 minutes.

Aspirin Delayed-Release Tablets Dissolution 711— Proceed as directed for Procedure for Method B under Apparatus 1 and Apparatus 2, Delayed-Release Dosage Forms. Apparatus 1: 100 rpm. Time: 90 minutes, for Buffer stage. Diluent— Prepare a mixture of 0.1 N hydrochloric acid and 0.20 M tribasic sodium phosphate (3:1), and adjust, if necessary, with 2 N hydrochloric acid or 2 N sodium hydroxide to a pH of 6.8 ± 0.05. Procedure— Determine the amount of C9H8O4 dissolved by determining UV absorbances at the wavelength of the isosbestic point of aspirin and salicylic acid (about 280 nm in the Acid stage, and about 265 nm in the Buffer stage), using a filtered portion of the solution under test, diluted, if necessary, with 0.1 N hydrochloric acid (analyzing the Acid stage) and with Diluent (analyzing the Buffer stage), in comparison with a Standard solution having a known concentration of USP Aspirin RS in the same Medium.

<724> DRUG RELEASE Transdermal Delivery Systems Apparatus 5 (Paddle over Disk) Apparatus 6 (Cylinder) Apparatus 7 (Reciprocating Holder)

Apparatus 5 (Paddle over Disk)

Apparatus 6 (Cylinder)

Apparatus 7 (Reciprocating Holder) Reciprocating Disk Sample Holder

Apparatus 7 (Reciprocating Holder) Transdermal System Holder—Angled Disk

Apparatus 7 (Reciprocating Holder) Transdermal System Holder—Cylinder.

Apparatus 7 (Reciprocating Holder) Oral Extended-Release Tablet Holder—Rod, Pointed for Gluing.

Apparatus 7 (Reciprocating Holder) Oral Extended-Release Tablet Holder—Spring Holder

Acceptance Table DRUG RELEASE :TRANSDERMAL DELIVERY SYSTEMS Level Number Tested Criteria L1 6 No individual value lies outside the stated range. L2 The average value of the 12 units (L1 + L2) lies within the stated range. No individual value is outside the stated range by more than 10% of the average of the stated range. L3 12 The average value of the 24 units (L1 + L2 + L3) lies within the stated range. Not more than 2 of the 24 units are outside the stated range by more than 10% of the average of the stated range; and none of the units is outside the stated range by more than 20% of the average of the stated range.

Acceptance Table DRUG RELEASE :coated tablet drug delivery systems Level Number Tested Criteria L1 6 No individual value lies outside each of the stated ranges and no individual value is less than the stated amount at the final test time. L2 The average value of the 12 units (L1 + L2) lies within each of the stated ranges and is not less than the stated amount at the final test time; none is more than 10% of labeled content outside each of the stated ranges; and none is more than 10% of labeled content below the stated amount at the final test time. L3 12 The average value of the 24 units (L1 + L2 + L3) lies within each of the stated ranges, and is not less than the stated amount at the final test time; not more than 2 of the 24 units are more than 10% of labeled content outside each of the stated ranges; not more than 2 of the 24 units are more than 10% of labeled content below the stated amount at the final test time; and none of the units is more than 20% of labeled content outside each of the stated ranges or more than 20% of labeled content below the stated amount at the final test time.