法规列表-ANDISSO

ChP<0931> Apparatus 2 (paddle apparatus)

ChP

Paddle shaft

Stirring paddle diameter:9.75mm±0.35mm

Material: made of stainless steel or other inert material

Blade

Paddle symmetry: not exceed 0.5mm

Blade bottom length: 42.0mm

Blade top length: 74.0mm±5.0mm

Paddle blade height: 19.0mm±0.5mm

Verticality: 90°±0.2°

Radian radius of paddle blade: 41.5mm

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

Vessel

1,000 mL hemispherical cup vessel

Inner diameter: 102mm±4mm

Height: 185mm±25mm1000mL

　第二法（桨法）

　　除将转篮换成搅拌桨外，其他装置和要求与第一法相同。搅拌桨的下端及桨叶部分可涂适当的惰性材料（如聚四氟乙烯），其形状尺寸如图2所示。桨杆对称度（即桨轴左侧距桨叶左边缘距离与桨轴右侧距桨叶右边缘距离之差）不得超过0.5mm，桨轴和桨叶垂直度90°±0.2°；桨杆旋转时，桨轴与溶出杯的垂直轴在任一点的偏差均不得大于2mm；搅拌桨旋转时A、B两点的摆动幅度不得超过0.5mm。

USP <711> APPARATUS 2

USP

Paddle shaft

Stirring paddle diameter: 9.4mm-10.1mm

Material: made of stainless steel or other inert material

Blade

Blade bottom length: 42.0mm

Blade top length: 74.0mm-75.0mm

Paddle blade height: 19.0mm±0.5mm

Radian radius of paddle blade: 41.5mm

Distance from blade 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

Apparatus 2 (Paddle Apparatus)

Use the assembly from Apparatus 1, except that a paddle formed from a blade and a shaft is used as the stirring element. The shaft is positioned so that its axis is NMT 2 mm from the vertical axis of the vessel at any point and rotates smoothly without significant wobble that could affect the results. The vertical center line of the blade passes 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 vessel is maintained during the test. The metallic or suitably inert, rigid blade and shaft compose a single entity. A suitable two-part, detachable design may be used, provided that the assembly remains firmly engaged during the test. The paddle blade and shaft may be coated with a suitable coating so as to make both of them inert. The dosage unit is allowed to sink to the bottom of the vessel before rotation of the blade is started. A small, loose piece of nonreactive material, such as NMT a few turns of wire helix, may be attached to dosage units that would otherwise float. An alternative sinker device is shown in Figure 2a. Other validated sinker devices may be used.

EP <2.9.3> APPARATUS 2

EP

Paddle shaft

Stirring paddle diameter:9.4mm-10.1mm

Material: made of stainless steel or other inert material

Blade

Paddle symmetry: not exceed 0.5mm

Blade bottom length: 42.0mm

Blade top length: 74.5mm±0.5mm

Paddle blade height: 19.0mm±0.5mm

Radian radius of paddle blade: 41.5mm

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

Vessel

1 L hemispherical cup vessel

Inner diameter: 98mm-106mm

Height: 160mm-210mm

Apparatus 2 (Paddle apparatus).

Use the assembly fromApparatus 1, except that a paddle formed from a blade and ashaft is used as the stirring element. The shaft is positioned sothat its axis is not more than 2 mm from the vertical axis of thevessel, at any point, and rotates smoothly without significantwobble that could affect the results. The vertical center lineof the blade passes through the axis of the shaft so that thebottom of the blade is flush with the bottom of the shaft. Thepaddle conforms to the specifications shown in Figure 2.9.3.-2The distance of 25 + 2 mm between the bottom of the bladeand the inside bottom of the vessel is maintained duringthe test. The metallic or suitably inert, rigid blade and shaftcomprise a single entity. A suitable two-part detachable designmay be used provided the assembly remains firmly engagedduring the test. The paddle blade and shaft may be coated witha suitable coating so as to make them inert. The dosage unitis allowed to sink to the bottom of the vessel before rotationof the blade is started. A small, loose piece of non-reactivematerial, such as not more than a few turns of wire helix, maybe attached to dosage units that would otherwise float. Analternative sinker device is shown in Figure 2.9.3.-3. Othervalidated sinker devices may be used.