711 DISSOLUTION
This general chapter is harmonized with the corresponding texts of the European Pharmacopoeia and/or the Japane Pharmacopoeia. The pharmacopeias have undertaken not to make any unilateral change to this harmonized chapter.
Portions of the prent general chapter text that are national USP text, and therefore not part of the harmonized text, are marked with symbols () 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, u the one specified in the individual monograph. Where the label 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-relea articles is included in the individual monograph, the procedure and interpretation given for Delayed-Relea Dosage Forms is applied unless otherwi specified in the individual monograph. For hard or soft gelatin capsules and gelatin-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 t
han 6.8 is specified as the Medium in the individual monograph, the same Medium specified may be ud 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, pancreatin can be added to produce not more than 1750 USP Units of protea activity per 1000 mL.
USP R EFERENCE S TANDARDS11—USP Chlorpheniramine Maleate Extended-Relea Tablets RS. USP Prednisone Tablets RS.
APPARATUS
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Apparatus 1 (Basket Apparatus)正65537边形
The asmbly consists of the following: a vesl, which may be covered, made of glass or other inert, transparent material1; a motor; a metallic drive shaft; and a cylindrical basket. The vesl is partially immerd 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 vesl at 37 ± 0.5 during the test and keeping the bath fluid in constant, smooth motion. No part of the asmbly, including the environment in which the asmbly is placed, contributes significant motion, agitation, or vibration beyond that due to
the smoothly rotating stirring element. An apparatus that permits obrvation of the specimen and stirring element during the test is preferable. The vesl is cylindrical, 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 mm to 155 mm. Its sides are flanged at the top. A
fitted cover may be ud to retard evaporation.2 The shaft is positioned so that its axis is not more than 2 mm at any point from the vertical axis of the vesl and rotates smoothly and without significant wobble that could affect the results. A speed-regulating device is ud that
allows the shaft rotation speed to be lected 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) thick may be ud. A dosage unit is placed in a dry basket at the beginning of e
ach test. The distance between the inside bottom of the vesl and the bottom of the basket is maintained at 25 ± 2 mm during the test.
Figure 1. Basket Stirring Element
喝酒的坏处有哪些Apparatus 2 (Paddle Apparatus)
U the asmbly from Apparatus 1, except that a paddle formed from a blade and a shaft is ud as the stirring element. The shaft is positioned so that its axis is not more than 2 mm from the vertical axis of the vesl at any point and rotates smoothly without significant wobble that could affect the results. The vertical center line of the blade pass through the axis of the shaft so that the bottom of the blade is flush with the bottom of the shaft. The paddle conforms to the specifications shown in Figure 2. The distance of 25 ± 2 mm between the bottom of the blade and the inside bottom of the vesl is maintained during the test. The metallic or suitably inert, rigid blade and shaft compri a single entity. A suitable two-part detachable design may be ud provided the asmbly remains firmly engaged during the test. The paddle blade and shaft may be coated with a suitable coating so as to make them inert. The dosage unit is allowed to sink to the bottom of the vesl before rotation of the blade is started. A small, loo piece of nonreactive material, such as not more than a few turns of wire helix, may be attached to dosage units that would otherwi float. An alternative sinker device is shown in Figure 2a. Other validated sinker devices may be ud.
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Figure 2. Paddle Stirring Element
Figure 2a. Alternative sinker. All dimensions are expresd in mm.
Apparatus 3 (Reciprocating Cylinder)
NOT ACCEPTED BY THE JAPANESE PHARMACOPOEIA
The asmbly consists of a t of cylindrical, flat-bottomed glass vesls; a t of glass
reciprocating cylinders; inert fittings (stainless steel type 316 or other suitable material), and screens that are made of suitable nonsorbing and nonreactive material and that are designed to fit the tops and bottoms of the reciprocating cylinders; and a motor and drive asmbly to reciprocate the cylind
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ers vertically inside the vesls and, if desired, index the reciprocating cylinders horizontally to a different row of vesls. The vesls are partially immerd in a suitable water bath of any convenient size that permits holding the temperature at 37 ± 0.5 during the test. No part of the asmbly, including the environment in which the asmbly is placed, contributes significant motion, agitation, or vibration beyond that due to the smooth, vertically reciprocating cylinder. A device is ud that allows the
reciprocation rate to be lected and maintained at the specified dip rate given in the individual monograph within ±5%. An apparatus that permits obrvation of the specimens and reciprocating cylinders is preferable. The vesls are provided with an evaporation cap that remains in place for the duration of the test. The components conform to the dimensions
委婉表白暗示语句杏花公园shown in Figure 3 unless otherwi specified in the individual monograph.
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