1.1 本实践建立了一种基于总有机碳（TOC）属性的制药用水实时释放测试（RTRT）方法，该方法使用在线总有机碳（OLTOC）仪器，符合当前监管思路。 1.2 本规程与相关ASTM国际委员会E55制药产品制造标准、ICH协调三方指南、美国FDA PAT指南和美国FDA制药cGMP的概念相协调或支持。 1.3 本规程不提供被视为制药行业标准规程的制药程序的一般指导信息。本实践为非标准化程序提供了具体指导。 1.4 本规程不涉及用户的各种风险、变更或质量管理体系内部程序。 与本实践相关的总体项目努力应与制药用水的TOC浓度规范不合格的总体风险成比例。 1.5 本实践并不旨在确定如何遵守药典。选择的RTRT方法必须确保符合用户当前要求的药典。然而，遵守药典TOC方法并不一定足以满足当前RTRT的监管期望。 1.6 本规程无意取代或取代药典生物负载测试要求。它严格适用于水质的总有机碳属性。 1.7 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。 ====意义和用途====== 5.1 制药用水是制药和生物制药制造中最常见的成分。水的可接受纯度对最终药物产品的质量很重要。TOC浓度是该水纯度的关键指标和属性，也是对水净化系统整体性能的重要监测。TOC分析是对水中所有共价结合碳的测量，不包括二氧化碳（CO）形式的碳 2. )，碳酸氢盐图标（HCO 3. – )，或碳酸盐离子（CO 3. 2– )，并报告为每体积有机碳的质量。 5.2 本规程的应用提供了相关信息，以就符合药物总有机碳浓度规范的水释放作出知情决定。

1.1 This practice establishes an approach to the real-time release testing (RTRT) of pharmaceutical water based on the total organic carbon (TOC) attribute using on-line total organic carbon (OLTOC) instrumentation that is in agreement with current regulatory thinking. 1.2 This practice is harmonized with or supports the concepts of relevant ASTM International Committee E55 on Manufacture of Pharmaceutical Products standards, ICH Harmonized Tripartite Guidelines, the U.S. FDA PAT Guidance, and U.S. FDA Pharmaceutical cGMPs. 1.3 This practice does not provide general guidance information for pharmaceutical procedures that are considered standard practice in the pharmaceutical industry. This practice provides specific guidance for non-standardized procedures. 1.4 This practice does not address the user’s various internal procedures for risk, change, or quality management systems. The overall project effort associated with this practice shall be proportional to the overall risk of failing the pharmaceutical water’s TOC concentration specification. 1.5 This practice does not purport to establish how to comply with pharmacopeias. The RTRT methodology selected must assure compliance with the user’s current required pharmacopeias. However, compliance with pharmacopeia TOC methods is not necessarily sufficient to meet current regulatory expectations for RTRT. 1.6 This practice does not purport to substitute for or replace compendial bioburden testing requirements. It is strictly applicable to the TOC attribute of water quality. 1.7 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. ====== Significance And Use ====== 5.1 Pharmaceutical water is the most common component or ingredient used in pharmaceutical and biopharmaceutical manufacturing. Acceptable purity of the water is important to the quality of the final pharmaceutical product. TOC concentration is a key indicator and attribute of the purity of this water and also an important monitor of the overall performance of the water purification system. TOC analysis is the measurement of all the covalently bound carbon present in the water, not including carbon in the form of carbon dioxide (CO 2 ), bicarbonate icon (HCO 3 – ), or carbonate ion (CO 3 2– ), and is reported as the mass of organic carbon per volume. 5.2 Application of this practice provides pertinent information to make informed decisions on the release of water meeting pharmaceutical TOC concentration specifications.