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现行 ASTM E2503-13(2020)
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Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus 篮式和桨式溶解仪器的标准实践
发布日期: 2020-04-01
1.1 本规程涵盖桨叶和篮溶解装置的设置和校准。 1.2 本规程的使用可适用于经修改以实现自动溶解试验的仪器(即容器底部的阀门或通过轴进行采样)。 1.3 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 2.1 本规程概述了桨式和篮式溶解装置的机械校准程序,以确保结果的再现性。 2.2 一旦装置符合本规程中包括的所有机械规范,则认为其已校准,无需使用溶出校准片进行进一步校准。
1.1 This practice covers the set-up and calibration of the paddle and basket dissolution apparatus. 1.2 Use of this practice may be applied to apparatus that have been modified to enable automatic dissolution testing (that is, a valve in the bottom of the vessel or sampling through the shaft). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 2.1 This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure reproducibility of results. 2.2 Once a unit meets all of the mechanical specifications included in this practice, it is considered calibrated and further calibration with dissolution calibrator tablets is not required.
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归口单位: E55.12
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