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Standard Test Method for Carbonizable Substances in Paraffin Wax 石蜡中碳化物质的标准试验方法
发布日期: 2017-06-01
1.1 本试验方法包括石蜡中可碳化物质的测定。本试验方法适用于美国国家处方集定义的药用石蜡,熔点根据试验方法确定 D87 ,介于117之间 华氏度和149度 华氏度(47 °C和65 °C)。 1.2 以英寸-磅为单位的数值应视为标准值。括号中给出的值是到国际单位制的数学转换,仅供参考,不被视为标准值。 1.3 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和健康实践,并确定监管限制的适用性。 具体警告声明见 附件A1 . 1.4 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====== 4.1 本试验方法用于确定药用石蜡是否符合美国国家处方集规定的质量标准。
1.1 This test method covers determination of carbonizable substances in paraffin wax. The test method is applicable to paraffin wax for pharmaceutical use, as defined by the U.S. National Formulary, with a melting point as determined in accordance with Test Method D87 , between 117 °F and 149 °F (47 °C and 65 °C). 1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.3 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 and health practices and determine the applicability of regulatory limitations prior to use. Specific warning statements are given in Annex A1 . 1.4 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 ====== 4.1 This test method is a means for ascertaining whether pharmaceutical paraffin wax conforms to the standards for quality prescribed by the U.S. National Formulary.
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归口单位: D02.10
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