Transcription of DISINTEGRATION - USP–NF | USP-NF
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DISINTEGRATION - USP–NF | USP-NF
Revision Bulletin 701 DISINTEGRATION 1 Official August 1, 2008 Change to read:APPARATUSThe apparatus consists of a basket-rack assem-bly, a 1000-mL, low-form beaker, 138 to 160 mmin height and having an inside diameter of 97 to115 mm for the immersion fluid, a thermostatic ar-rangement for heating the fluid between 35 and 701 DISINTEGRATION39 , and a device for raising and lowering the bas-ket in the immersion fluid at a constant frequencyThis general chapter is harmonized with the cor-rate between 29 and 32 cycles per minute throughresponding texts of the european Pharmacopoeiaa distance of not less than 53 mm and not moreand/or the Japanese pharmacopoeia . The texts ofthan 57 mm. The volume of the fluid in the vesselthese pharmacopeias are therefore interchangeable,is such that at the highest point of the upwardand the methods of the european Pharmacopoeiastroke the wire mesh remains at least 15 mm be-and/or the Japanese pharmacopoeia may be usedlow the surface of the fluid and descends to notfor demonstration of compliance instead of theless than 25 mm from the bottom of the vessel onpresent general chapter.
and the methods of the European Pharmacopoeia stroke the wire mesh remains at least 15 mm be-and/or the Japanese Pharmacopoeia may be used ... states that the tablets or capsules are intended forside diameter of 20.7 to 23 mm and a wall 1.0 to use as troches, or are to be chewed, or are designed 2.8 mm thick; the tubes are held in a vertical ...
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