Immediate-Release Dosage Forms
Unless otherwise specified in the individual monograph, the requirements are met if the quantities of active ingredient dissolved from the dosage units tested conform to Acceptance Table 1. Continue testing through the three stages unless the results conform at either S1 or S2. The quantity (Q) is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labeled content of the dosage unit; the 5%, 15%, and 25% values in Acceptance Table 1 are percentages of the labeled content so that these values and Q are in the same terms.
Immediate-Release Dosage Forms Pooled Sample
Unless otherwise specified in the individual monograph, the requirements are met if the quantities of active ingredient dissolved from the pooled sample conform to the accompanying Acceptance Table for a Pooled Sample. Continue testing through the three stages unless the results conform at either S1 or S2. The quantity (Q) is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labeled content.
Extended-Release Dosage Forms
Unless otherwise specified in the individual monograph, the requirements are met if the quantities of active ingredient dissolved from the dosage units tested conform to Acceptance Table 2. Continue testing through the three levels unless the results conform at either L1 or L2. Limits on the amounts of active ingredient dissolved are expressed in terms of the percentage of labeled content. The limits embrace each value of Qi, the amount dissolved at each specified fractional dosing interval. Where more than one range is specified in the individual monograph, the acceptance criteria apply individually to each range.
Delayed-Release Dosage Forms
Acid stage: Unless otherwise specified in the individual monograph, the requirements of this portion of the test are met if the quantities, based on the percentage of the labeled content, of active ingredient dissolved from the units tested conform to Acceptance Table 3. Continue testing through all levels unless the results of both the Acid Stage and Buffer Stage conform at an earlier level.
Buffer stage: Unless otherwise specified in the individual monograph, the requirements are met if the quantities of active ingredient dissolved from the units tested conform to Acceptance Table 4. Continue testing through the three levels unless the results of both stages conform at an earlier level. The value of Q in Acceptance Table 4 is 75% dissolved unless otherwise specified in the individual monograph. The quantity (Q) specified in the individual monograph is the total amount of active ingredient dissolved in both the Acid Stage and the Buffer Stage, expressed as a percentage of the labeled content. The 5%, 15%, and 25% values in Acceptance Table 4 are percentages of the labeled content so that these values and Q are in the same terms.
Reference: USP 〈711〉 DISSOLUTION
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