711 DISSOLUTION This general chapter is harmonized with the corresponding texts of the European Pharmacopoeia and/or the Japanese Pharmacopoeia. These pharmacopeias have undertaken not to make any unilateral change to this harmonized chapter. Portions of the present general chapter text that are national USP text, and therefore not part of the harmonized text, are marked withsymbols ( ) to specify this fact.
This test is provided to determine compliance with the dissolution requirements where stated in the individual monograph for dosage forms administered orally. In this general chapter, a dosage unit is defined as 1 tablet or 1 capsule or the amount specified. Of the types of apparatus described herein, use the one specified in the individual monograph. Where thelabel states that an article is enteric-coated, and where a dissolution or disintegration test that does not specifically state that it is to be applied to delayed-release articles is included in the individual monograph, the procedure and interpretation given for Delayed-Release Dosage Forms is applied unless otherwise specified in the individual monograph. For hard or soft gelatin capsules andgelatin-coated tablets that do not conform to the Dissolution specification, repeat the test as follows. 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 media with a pH of 6.8 or greater, pancreatincan be added to produce not more than 1750 USP Units of protease activity per 1000 mL.
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USP Reference Standards 11 — USP Chlorpheniramine Maleate Extended-Release Tablets RS. USP Prednisone Tablets RS. USP Salicylic Acid Tablets RS.
APPARATUS Apparatus 1 (Basket Apparatus) The assemblyconsists of the following: a vessel, which may be covered, made of glass or other inert, transparent material1; a motor; a metallic drive shaft; and a cylindrical basket. The vessel is partially immersed in a suitable water bath of any convenient size or heated by a suitable device such as a heating jacket. The water bath or heating device permits holding the temperature inside the vessel at 37 ± 0.5during the test and keeping the bath fluid in constant, smooth motion. No part of the assembly, including the environment in which the assembly is placed, contributes significant motion, agitation, or vibration beyond that due to the smoothly rotating stirring element. An apparatus that permits observation of the specimen and stirring element during the test is preferable. The vessel iscylindrical, with a hemispherical bottom and with one of the following dimensions and capacities: for a nominal capacity of 1 L, the height is 160 mm to 210 mm and its inside diameter is 98 mm to 106 mm; for a nominal capacity of 2 L, the height is 280 mm to 300 mm and its inside diameter is 98 mm to 106 mm; and for a nominal capacity of 4 L, the height is 280 mm to 300 mm and its inside diameter is 145 mmto 155 mm . Its sides are flanged at the top. A fitted cover may be used to retard evaporation.2 The shaft is positioned so that its axis is not more
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than 2 mm at any point from the vertical axis of the vessel and rotates smoothly and without significant wobble that could affect the results.A speed-regulating device is used that allows the shaft rotation speed to be selected and maintained at the specified rate given in the individual monograph, within ±4%. Shaft and basket components of the stirring element are fabricated of stainless steel, type 316, or other inert material, to the specifications shown in Figure 1. A basket having a gold coating of about 0.0001 inch (2.5 µm)...