USP-711-溶出度2012年2月最新美国药典溶出度检查.pdfVIP

Revision Bulletin Official February 1, 2012 〈711〉 Dissolution 1 1 material ; a motor; a metallic drive shaft; and a cylindrical 〈711〉 DISSOLUTION 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 This general chapter is harmonized with the correspond- permits holding the temperature inside the vessel at ing texts of the European Pharmacopoeia and/or the Japa- 37 ± 0.5° during the test and keeping the bath fluid in con- nese Pharmacopoeia. These pharmacopeias have undertaken stant, smooth motion. No part of the assembly, including not to make any unilateral change to this harmonized the environment in which the assembly is placed, contrib- chapter. utes significant motion, agitation, or vibration beyond that Portions of the present general chapter text that are na- due to the smoothly rotating stirring element. An apparatus tional USP text, and therefore not part of the harmonized that permits observation of the specimen and stirring ele- text, are marked with symbols () to specify this fact. ment during the test is preferable. The vessel is cylindrical, This test is provided to determine compliance with the with a hemispheri