Transcription of DISSOLUTION - USP-NF
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DISSOLUTION - USP-NF
Revision BulletinOfficial February 1, 2012 711 Dissolution1material1; a motor; a metallic drive shaft; and a cylindrical 711 DISSOLUTION basket. The vessel is partially immersed in a suitable waterbath of any convenient size or heated by a suitable devicesuch as a heating jacket. The water bath or heating devicepermits holding the temperature inside the vessel atThis general chapter is harmonized with the correspond-37 during the test and keeping the bath fluid in con-ing texts of the European Pharmacopoeia and/or the Japa-stant, smooth motion. No part of the assembly, includingnese Pharmacopoeia. These pharmacopeias have undertakenthe environment in which the assembly is placed, contrib-not to make any unilateral change to this harmonizedutes significant motion, agitation, or vibration beyond to the smoothly rotating stirring element. An apparatusPortions of the present general chapter text that are na-that permits observation of the specimen and stirring ele-tional USP text, and therefore not part of the harmonizedment during the test is preferable.
lected and maintained at the specified dip rate given in the individual monograph within ±5%. An apparatus that permits observation of the specimens and reciprocating cyl-inders is preferable. The vessels are provided with an evap-oration cap that remains in place for the duration of the test. The components conform to the dimensions shown in
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