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硫酸灰分药典翻译


硫酸灰分
中国药典:
取供试品 1.0~2.0g 或各药品项下规定的重量,置已炽灼至恒重的坩埚中,(如 供试品分子中含有碱金属或氟元素,则应使用铂坩埚)中,精密称定,缓缓炽灼至完 全炭化,放冷;除另有规定外,加硫酸 0.5~1ml 使湿润,低温加热至硫酸蒸气除尽 后,在 700~800℃炽灼使完全灰化,移置干燥器内,放冷,精密称定后,再在 700~ 800℃炽

灼至恒重,即得。如需将残渣留作重金属检查,则炽灼温度必须控制在 500~ 600℃。

美国药典
281 RESIDUE ON IGNITION

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 pharmacopeias 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 Pharmacopeia general chapter. These pharmacopeias have undertaken not to make any unilateral change to this harmonized chapter. 这个章节的部分与欧洲药典和日本药典的相应内容统一。而与其没有统一的部分则用( ) 标识出来。因此,药典中统一部分的内容是通用的,欧洲药典和(或)日本药典中关于灼炽 残渣的检测方法可以代替现行的美国药典对应章节中的方法。 这几部药典对这个统一章节不 会做出任何单方面的改动。 The Residue on Ignition/Sulfated Ash test uses 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. 所谓炽灼残渣(或硫酸盐灰分)的检测,就是测出样品经硫酸碳化再炽灼,没有从其中挥 发出的剩余部分的总量。这种方法通常用来检测有机物质中无机杂质的含量 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:在 600±50℃下炽灼一个合适材质的坩埚(例如,二氧化硅,铂金,石英,或者瓷 质)30 分钟,在干燥器(硅胶或其他合适干燥剂)中冷却,精确称量它的质量。精确称取 1~2 g 或 个别文献特定说明质量的样品,放在之前冷却后的坩埚中。

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, and ignite at 600 ± 50 , monograph, moisten the residue with a small amount (usually 1 mL) of sulfuric acid; heat gently until white fumes are no longer evolved; unless another temperature is specified in the individual until the residue is completely incinerated. Ensure that flames are not

produced at any time during the procedure. Cool the crucible in a desiccator (silica gel or other suitable desiccant), weigh accurately, and calculate the percentage of residue. 用少量(通常 1 mL)硫酸润湿样品,然后在尽量低的温度下慢慢加热,直至样品完全 烧焦。冷却;然后☆除非个别文献另有说明 又用少量(通常 1 mL)硫酸润湿;缓慢加热至 不再有白烟生成;再在 600±50℃下炽灼, 除非个别文献另有说明 直至样品完全碳化。确 保在整个程序中没有火焰生成。在干燥器(硅胶或其他合适干燥剂)中冷却,精确称重,然 后计算残渣所占百分比。 Unless otherwise specified, if the amount of the residue so obtained exceeds the limit specified in the individual monograph, repeat the moistening with sulfuric acid, heating and igniting as before, using a 30-minute ignition period, until two consecutive weighings of the residue do not differ by more than 0.5 mg or until the percentage of residue complies with the limit in the individual monograph. 如果算得的数值明显超过特定文献的限定,则需重复以上硫酸润湿、加热、炽灼的过 程,炽灼 30 分钟,直至有连续两次测得的残渣的质量相差小于 0.5 mg,或者算得的残渣百 分比在特定文献的限度内。 Conduct the ignition in a well-ventilated hood, but protected from air currents, and at as low a temperature as is possible to effect the complete combustion of the carbon. A muffle furnace may be used, if desired, and its use is recommended for the final ignition at 600 ± 50 . 在通风良好的环境下进行炽灼,但是要防止气流,并且在低的温度下尽量保证碳的完全燃 烧。如果需要,可以用马弗炉,这样可以确保最后炽灼的温度在 600±50℃。 Calibration of the muffle furnace may be carried out using an appropriate digital temperature meter and a working thermocouple probe calibrated against a standard thermocouple traceable to the National Institute of Standards and Technology. Verify the accuracy of the measuring and controlling circuitry of the muffle furnace by checking the positions in the furnace at the control set point temperature of intended use. Select positions that reflect the eventual method of use with respect to location of the specimen under test. The tolerance is ± 25 at each position measured. 马弗炉的校准, 可以通过使用适合的电子温度仪和一个工作的热电偶探头来校对来自国家 标准和技术机构的标准热电偶。 确保称量的精确度, 通过检查马弗炉设定温度与控制温度来 确保控制电路。选择能够反应测试下样品可能使用方法的位置。每个测量位置的误差是± 25℃。

欧洲药典:
Sulfated ash Ignite a suitable crucible (for example, silica, platinum, porcelain or quartz) at 600 ± 50 ° for 30 min, allow to cool in a desiccator over silica gel or other suitable desiccant C and weigh. Place the prescribed amount of the substance to be examined in the crucible and weigh. Moisten the substance to be examined with a small amount of sulfuric acid R (usually 1 mL) and heat gently at as low a temperature as practicable until the sample is thoroughly charred. After cooling, moisten the residue with a small amount of sulfuric acid R (usually 1 mL), heat gently until white fumes are no longer evolved and ignite at 600 ± 50 ° until the residue is completely incinerated. Ensure that flames are not produced at C any time during the procedure. Allow the crucible to cool in a desiccator over silica gel or other suitable desiccant, weigh it again and calculate the percentage of residue. 在 600±50℃下炽灼一个合适材质的坩埚(例如,二氧化硅,铂金,石英,或者瓷质) 30 分钟,在盛有硅胶或其他合适干燥剂的干燥器中冷却,精确称量它的质量。称取订明质 量的样品,放在之前冷却后的坩埚中。用少量(通常 1 mL)硫酸润湿样品,然后在尽量低 的温度下慢慢加热,直至样品完全烧焦。冷却;然后又用少量(通常 1 mL)硫酸润湿;缓 慢加热至不再有白烟生成;再在 600±50℃下炽灼,直至样品完全碳化。确保在整个程序中 没有火焰生成。在盛有硅胶或其他合适干燥剂的干燥器中冷却,再次称重,然后计算残渣所 占百分比。 If the amount of the residue so obtained exceeds the prescribed limit, repeat the moistening with sulfuric acid R and ignition, as previously, for 30 min periods until 2 consecutive weighings do not differ by more than 0.5 mg or until the percentage of residue complies with the prescribed limit. 如果算得的数值明显超过订明限定,则需重复以上硫酸润湿、加热、炽灼的过程,炽灼 30 分钟,直至有连续两次测得的残渣的质量相差小于 0.5 mg,或者算得的残渣百分比在订 明限度内。 The amount of substance used for the test (usually 1-2 g) is chosen so that at the prescribed limit the mass of the residue (usually about 1 mg) can be measured with sufficient accuracy. 为了保证在订明的限度内,残渣的总质量有足够的精度(通常约 1 mg),用于检测的样 品也需适量(通常约 1~2 g)。


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