The assembly consists of the following: a covered vessel made of glass or other inert, transparent material 1 a motor a metallic drive shaft and a cylindrical basket.
For media with a pH of 6.8 or greater, pancreatin can be added to produce not more than 1750 USP Units of protease activity per 1000 mL. Where water or a medium with a pH of less than 6.8 is specified as the Medium in the individual monograph, the same Medium specified may be used with the addition of purified pepsin that results in an activity of 750,000 Units or less per 1000 mL. For hard or soft gelatin capsules and gelatin-coated tablets that do not conform to the Dissolution specification, repeat the test as follows. Where the label states that an article is enteric-coated, and a dissolution or disintegration test that does not specifically state that it is to be applied to enteric-coated articles is included in the individual monograph, the test for Delayed-Release Articles under Drug Release 724 is applied unless otherwise specified in the individual monograph. Of the types of apparatus described herein, use the one specified in the individual monograph. This test is provided to determine compliance with the dissolution requirements where stated in the individual monograph for a tablet or capsule dosage form.