USP35-643 总有机碳.docVIP

USP35-643 总有机碳 Total organic carbon (TOC) is an indirect measure of organic molecules present in pharmaceutical waters measured as carbon. Organic molecules are introduced into the water from the source water, from purification and distribution system materials, and from biofilm growing in the system. TOC can also be used as a process control attribute to monitor the performance of unit operations comprising the purification and distribution system. A TOC measurement is not a replacement test for endotoxin or microbiological control. While there can be a qualitative relationship between a food source (TOC) and microbiological activity, there is no direct numerical correlation. 总有机碳(TOC)是通过测量碳来间接测量制药用水中存在的有机分子的一种方法。水中的有机物质产生于源水，水的净化与分配系统以及系统内生物膜的生长。TOC也可用作一个过程控制特性以监测包括净化和分配系统的单元操作的性能。TOC测试并不是一个替代控制内毒素或微生物的测试。虽然在食物来源(TOC)和微生物活动之间存在定性关联，但是它们没有数值上的直接相互关系。 A number of acceptable methods exist for analyzing TOC. This chapter does not endorse, limit, or prevent any technologies from being used, but this chapter provides guidance on how to qualify these analytical technologies for use as well as guidance on how to interpret instrument results for use as a limit test. 存在一些令人满意的用于分析TOC的方法。本章不局限于或限制可被使用的可替代的技术，仅提供关于如何证明这些技术具备资格的指导和如何解释用于限度检查的仪器结果的指导。 Apparatus commonly used to determine TOC in water for pharmaceutical use have in common the objective of oxidizing the organic molecules in the water to produce carbon dioxide followed by the measurement of the amount of carbon dioxide produced. Then the amount of CO2 produced is determined and used to calculate the organic carbon concentration in the water. 用来测定TOC的分析技术原理是基于将水中的有机物质完全氧化为CO2，检测所产生的CO2量，并用响应值来表示有机碳的浓度。 All technologies must discriminate between the inorganic carbon, which may be present in the water from sources such as dissolved CO2 and bicarbonate, and the CO2 generated from the oxidation of organic molecules in the sample. The discrimination may be accomplished either by determining the inorganic carbon and sub