Dissolution is a critical parameter for pharmaceutical solid dosage form. In this article we discuss about the dissolution acceptance criteria as per BP.
Conventional-release solid dosage forms
Unless otherwise specified, the requirements are met if the quantities of active substance dissolved from the dosage units tested conform to below table. Continue testing through the S3 levels unless the results conform at either S1 or S2. The quantity Q, is the specified amount of dissolved active substance, expressed as a percentage of the labelled content; the 5 per cent, 15 per cent, and 25 per cent values in the Table are percentages of the labelled content so that these values and Q are in the same terms.
Prolonged-release dosage forms
Unless otherwise specified, the requirements are met if the quantities of active substance dissolved from the dosage units tested conform to below table. Continue testing through the L3 levels unless the results conform at either L1 or L2. Limits on the amounts of active substance dissolved are expressed in terms of the percentage of labelled content. The limits embrace each value of Qi, the amount dissolved at each specified fractional dosing interval. Where more than one range is specified, the acceptance criteria apply individually to each range.
Delayed-release dosage forms
Acid stage: Unless otherwise specified, the requirements of this portion of the test are met if the quantities, based on the percentage of the labelled content of active substance dissolved from the units tested conform to below table. Continue testing through the 3 levels unless the results of both acid and buffer stages conform at an earlier level.
Buffer stage: Unless otherwise specified, the requirements are met if the quantities of active substance dissolved from the units tested conform to below table. Continue testing through the 3 levels unless the results of both stages conform at an earlier level. The value of Q in below table is 75 per cent dissolved unless otherwise specified. The quantity, Q, is the specified total amount of active substance dissolved in both the acid and buffer stages, expressed as a percentage of the labelled content. The 5 per cent, 15 per cent and 25 per cent values in the Table are percentages of the labelled content so that these values and Q are in the same terms.
Related:
إرسال تعليق