The vessels are partially immersed in a suitable water bath of any convenient size that permits holding the temperature at 37 0.5 during the test.
The assembly consists of a set of cylindrical, flat-bottomed glass vessels a set of glass reciprocating cylinders stainless steel fittings (type 316 or equivalent) and screens that are made of suitable nonsorbing and nonreactive material and that are designed to fit the tops and bottoms of the reciprocating cylinders and a motor and drive assembly to reciprocate the cylinders vertically inside the vessels and, if desired, index the reciprocating cylinders horizontally to a different row of vessels. Where more than one range is specified in the individual monograph, the acceptance criteria apply individually to each range. The limits embrace each value of Q i, the amount dissolved at each specified fractional dosing interval. Limits on the amounts of active ingredient dissolved are expressed in terms of the percentage of labeled content. 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 1.Ĭontinue testing through the three levels unless the results conform at either L 1 or L 2. Specimens are to be withdrawn within a tolerance of 2 of the stated time. The test-time points, generally three, are expressed in hours. Keep the vessel covered for the duration of the test, and verify the temperature of the mixture under test at suitable times.
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