USP 281中英文对照.doc

281 RESIDUE ON IGNITION 炽灼残渣 Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia. The portions that are not harmonized are marked with symbols(◆ ◆). The harmonized texts of these pharmacopoeias are therefore interchangeable, and the methods of the European Pharmacopoeia and/or the Japanese Pharmacopoeia may be used for demonstration of compliance instead of the present United States Pharmacopoeia general chapter. These pharmocopoeias have been undertaken not to make any unilateral change to this harmonized chapter. 此通则的各部分已经与欧洲药典和日本药典的对应部分做了协调。不一致的部分用符号（◆ ◆）来标明。因此，这些药典中协调一致的内容是可以互换的，欧洲药典和/或日本药典的方法可以替代美国药典的通则，用于显示符合性。对于这个协调一致的章节，这些药典已经承诺不进行任何单方变更。 The Residue on Ignition / Sulfated Ash test utilizes a procedure to measure the amount of residual substance not volatilized from a sample when the sample is ignited in the presence of sulfuric acid according to the procedure described below. This test is usually used for determining the content of inorganic impurities in an organic substance. 炽灼残渣/硫酸化灰分检测是当根据下面所述的步骤使样品在有硫酸的情况下灼烧后，测量未挥发的残留物质量的方法。该检验通常用用检测一个有机物质中的无机杂质的含量。 Procedure— Ignite a suitable crucible (for example, silica, platinum, quartz, or porcelain) at 600 ± 50 for 30 minutes, cool the crucible in a desiccator (silica gel or other suitable desiccant), and weigh it accurately. Weigh accurately ◆1 to 2 g of the substance, or◆ the amount specified in the individual monograph, in the crucible. 步骤：取一个适当的坩锅（例如，硅、铂、石英、或者瓷器），在600±50条件下灼烧30分钟，在干燥器（硅胶或者其他适合的干燥剂）中将该坩锅冷却，并精确称重。精确称取◆1-2克该物质，或者◆在具体的各论中规定的数量，于该坩锅中。 Moisten the sample with a small amount (usually 1 mL) of sulfuric acid, then heat gently at a temperature as low as practicable until the sample is thoroughly charred. Cool; then, ◆unless otherwise directed in the individual monograph, ◆moisten the residue with a small amount (usually 1 mL) of sulfuric acid; heat gently until white fumes are no longer evolved; and ignite