美国药典USP31翻译版.pdfVIP

ManyPharmacopeial articles either are hydrates or contain water in adsorbed form. As a result, the determination of the water content is important in demonstrating compliance with the Pharmacopeial standards. Generally one of the methods given below is called for in the individual monograph, depending upon the nature of the article. In rare cases, a choice is allowed between two methods. When the article contains water of hydration, the Method I (Titrimetric), the Method II (Azeotropic), or the Method III (Gravimetric) is employed, as directed in the individual monograph, and the requirement is given under the heading Water. 很多药典物品要么是水合物， 要么含有处于吸附状态的水。 因此，测定水分含量对于证实与药典标准 的符合性是很重要的。 通常，在具体的各论中会根据该物品的性质， 要求使用下面若干方法中的一个。 偶尔，会允许在 2 个方法中任选一个。当该物品含有水合状态的水，按照具体各论中的规定，使用方 法 I （滴定测量法）、方法 II （恒沸测量法）、或方法 III （重量分析法），这个要求在标题 水分 项 下给出。 The heading Loss on drying (see Loss on Drying 731) is used in those cases where the loss sustained on heating may be not entirely water. 干燥失重 干燥失重 在加热时的持续失重可能不全是水分的情况下，使用标题 （见 731）。 METHOD I (TITRIMETRIC) 方法 I （滴定测量法） Determine the water by Method Ia, unless otherwise specified in the individual monograph. 除非具体各论中另有规定，使用 方法 Ia 来测定水分。 Method Ia (Direct Titration) 方法 Ia （直接滴定） Principle — The titrimetric determination of water is based upon the quantitative reaction of water with an anhydrous solution of sulfur dioxide and iodine in the presence of a buffer that reacts with hydrogen ions. 原理：水分的滴定法检测是基于水与二氧化硫的无水溶液以及存在于缓冲液中与氢离子反应的碘之间 的定量反应。 In the original titrimetric solution, known as Karl Fischer Reagent, the sulfur dioxide and iodine are dissolved in pyridine and methanol. Th