ChP

Basket shaft

Diameter: 9.75mm±0.35mm

Material: made of stainless steel or other inert material

Rotating basket

Rotating basket Wire diameter: 0.28mm±0.03mm

Mesh: 0.40mm±0.04mm

Vent hole diameter: 2.0mm±0.5mm

Inner diameter of rotating basket: 20.2mm±1.00mm

Distance from basket bottom to vessel bottom: 25mm±2mm

Vessel

1,000 mL hemispherical cup vessel

Inner diameter: 102mm±4mm

Height: 185mm±25mm

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USP <711> APPARATUS 1
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　第一法（篮法）

　　（1）转篮  分篮体与篮轴两部分，均为不锈钢或其他惰性材料制成，其形状尺寸如图1所示。篮体A由方孔筛网（丝径为0.28mm±0.03mm，网孔为0.40mm±0.04mm）制成，呈圆柱形，转篮内径为20.2mm±1.0mm，上下两端都有封边。篮轴B的直径为9.75mm±0.35mm，轴的末端连一圆盘，作为转篮的盖；盖上有一通气孔（孔径为2.0mm±0.5mm）；盖边系两层，上层直径与转篮外径相同，下层直径与转篮内径相同；盖上的3个弹簧片与中心呈120°角。

　　（2）溶出杯  一般由硬质玻璃或其他惰性材料制成的底部为半球形的1000ml杯状容器，内径为102mm±4mm（圆柱部分内径最大值和内径最小值之差不得大于0.5mm），高为185mm±25mm；溶出杯配有适宜的盖子，盖上有适当的孔，中心孔为篮轴的位置，其他孔供取样或测量温度用。溶岀杯置恒温水浴或其他适当的加热装置中。

　　（3）篮轴与电动机相连，由速度调节装置控制电动机的转速，使篮轴的转速在各品种项下规定转速的±4%范围之内。运转时整套装置应保持平稳，均不能产生明显的晃动或振动（包括装置所处的环境）。转篮旋转时，篮轴与溶出杯的垂直轴在任一点的偏离均不得大于2mm，转篮下缘的摆动幅度不得偏离轴心1.0mm。

　　（4）仪器一般配有6套以上测定装置。

JP

Basket shaft

Diameter: 6.3mm-6.5mm/9.4mm-10.1mm

Material: made of stainless steel orother inert material

Rotating basket

Wire diameter: 0.25mm-0.31mm

Mesh: 0.36mm-0.44mm

Vent hole diameter: 2.0mm±0.5mm

Inner diameter of rotating basket:22.20mm±1.00mm

Distance from basket bottom to vessel bottom: 25mm±2mm

Vessel

1 L hemispherical cup vessel

Inner diameter: 98mm-106mm

Height: 160mm-210mm

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JP111

Basket shaft

Diameter: 6.3mm-6.5mm/9.4mm-10.1mm

Material: made of stainless steel orother inert material

Rotating basket

Wire diameter: 0.25mm-0.31mm

Mesh: 0.36mm-0.44mm

Vent hole diameter: 2.0mm±0.5mm

Inner diameter of rotating basket:22.20mm±1.00mm

Distance from basket bottom to vessel bottom: 25mm±2mm

Vessel

1 L hemispherical cup vessel

Inner diameter: 98mm-106mm

Height: 160mm-210mm

USP

Basket shaft

Diameter: 6.3mm-6.5mm/9.4mm-10.1mm

Material: made of stainless steel or other inert material

Rotating basket

Wire diameter: 0.22mm-0.31mm

Mesh: 0.36mm-0.44mm

Vent hole diameter: 2.0mm±0.5mm

Inner diameter of rotating basket: 20.20mm±1.00mm

Distance from basket bottom to vessel bottom: 25mm±2mm

Vessel

1 L hemispherical cup vessel

Inner diameter: 98mm-106mm

Height: 160mm-210mm

2 L hemispherical cup vessel

Inner diameter: 98mm-106mm

Height: 280mm-300mm

4 L hemispherical cup vessel

Inner diameter: 145mm-155mm

Height: 280mm-300mm

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Apparatus 1 (Basket Apparatus)
The assembly consists of the following: a vessel, which may be covered, and made of glass or other inert, transparent mate-rial;1 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 ± 0.5° during the test and keeps 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 of the stirring element during the test is preferable. The vessel 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 160–210 mm, and its inside diameter is 98–106 mm; ♦ for a nominal capacity of 2 L, the height is 280–300 mm, and its inside diameter is 98–106 mm; and for a nominal capacity of 4 L, the height is 280–300 mm, and its inside diameter is 145–155 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 NMT 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 mono-graph♦ 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 mm) thick may be used. A dosage unit is placed in a dry basket at the beginning of each test. The distance between the inside bottom of the vessel and the bottom of the basket is maintained at 25 ± 2 mm during the test.