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【原创】相应药典互译usp1051

  • songqingguo
    2009/07/15
  • 私聊

专业英语

  • CLEANING GLASS APPARATUS
    Success in conducting many Pharmacopeial assays and tests depends upon the utmost cleanliness of the glassware apparatus used. For example, the accuracy of the assays of heparin sodium and vitamin B12 activity, as well as the pyrogen and total organic carbon tests, are particularly dependent upon scrupulously clean glassware.
    One effective method used in the past for cleaning glassware is the application of hot nitric acid. A second traditional method for removing organic matter that does not require heat is the use of a chromic acid–sulfuric acid mixture. However, the chromic acid wash is not recommended because of the hazardous and toxic nature of the material.
    Several safer alternatives, including the use of cleansing agents, such as trisodium phosphate and synthetic detergents, have proven highly useful, but require prolonged rinsing. It may be useful to rinse with diluted nitric or sulfuric acid prior to rinsing with water. This operation will facilitate removal of residual alkaline material.
    For optical measurements, special care is required for cleaning containers, but the use of both chromic acid and highly alkaline solutions should be avoided.
    Effective removal of organic matter is very important for testing pharmaceutical waters in accordance with the general test chapter Total Organic Carbon 643. It has been demonstrated that an alkaline detergent with potassium hydroxide as the primary ingredient* leaves the least amount of organic matter residuals. Heating in a muffle furnace produces comparable results and is the least labor-intensive procedure; however, it requires specialized equipment.
    In all cases, it is important to verify that the cleaning procedure is appropriate for the particular test or assay being undertaken. This can be accomplished via blank runs, scientific judgments, residuals data from cleansing agent and detergent manufacturers, or other controls. Specifically, special care is required for cleaning containers for optical measurement applications; the use of highly alkaline and the no longer recommended chromic acid solutions should be avoided. Finally, a statement should be included in the cleaning protocol describing how the success of the cleaning procedure will be assessed.

    〈1051〉玻璃器皿的清洁
    很多药典分析及检测方法的成功实施取决于所用玻璃仪器的绝对洁净度,如肝素钠含量和维生素B12活性检测的准确性,再比如热源和总有机碳检测更是特别需要洁净度高的玻璃器皿。
    热硝酸是过去经常使用的一种非常有效的清洗玻璃器皿的方法,另一种传统的用于洗涤有机物而又不需加热的方法是使用铬酸-硫酸混合液,但考虑到其自身的危险性及毒性,我们不推荐使用铬酸。
    其他可供选择的比较安全的清洗方法包括使用各种清洁剂,如磷酸钠及各种合成去污剂,这种方法是非常有效的,但其缺点是需要长时间的冲洗。在用水冲洗之前,先用稀硝酸或稀硫酸淌洗时非常有用的,这样可以有效地去除残留的碱性物质。
    我们需特别注意用于光学检测的玻璃容器的清洗,这里应避免使用铬酸和强碱性溶液。
    在检测药用水时,为与〈643〉部分总有机碳检测章节相符,(所用玻璃容器)有机物的除去就显得尤为重要,研究表明使用以氢氧化钾为主要成分的碱性去污剂进行清洗,能将有机物残留量降到最少。使用马弗炉高温加热也能达到相当的效果,这种方法最节省人力、但需要特定设备。
    总之,要证明采用的清洗方法适用于所要进行的具体检测和分析操作是非常必要的,我们可以通过空白试验、科学判断、清洁剂残留数据、清洁剂制造商或其他方法来做到这一点。此外,我们需要特别注意用于光学检测玻璃容器的清洗,应避免使用强碱性洗涤剂和已不再推荐使用的铬酸溶液。最后,清洗方案中应该包括如何判断清洁是否成功的说明。
    请专家指证
  • 该帖子已被版主-影子加10积分,加2经验;加分理由:感谢分享
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  • songqingguo

    第1楼2009/07/15

    对不起,我发重了。刚到论坛发东西,没注意。

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  • 影子

    第2楼2009/07/15

    个人认为你的翻译非常准确,语言流畅且符合中国人的语言习惯。不知道是不是你自己翻译的,水平很高,欢迎多发这样的原创帖子

    songqingguo 发表:〈1051〉玻璃器皿的清洁
    很多药典分析及检测方法的成功实施取决于所用玻璃仪器的绝对洁净度,如肝素钠含量和维生素B12活性检测的准确性,再比如热源和总有机碳检测更是特别需要洁净度高的玻璃器皿。
    热硝酸是过去经常使用的一种非常有效的清洗玻璃器皿的方法,另一种传统的用于洗涤有机物而又不需加热的方法是使用铬酸-硫酸混合液,但考虑到其自身的危险性及毒性,我们不推荐使用铬酸。
    其他可供选择的比较安全的清洗方法包括使用各种清洁剂,如磷酸钠及各种合成去污剂,这种方法是非常有效的,但其缺点是需要长时间的冲洗。在用水冲洗之前,先用稀硝酸或稀硫酸淌洗时非常有用的,这样可以有效地去除残留的碱性物质。
    我们需特别注意用于光学检测的玻璃容器的清洗,这里应避免使用铬酸和强碱性溶液。
    在检测药用水时,为与〈643〉部分总有机碳检测章节相符,(所用玻璃容器)有机物的除去就显得尤为重要,研究表明使用以氢氧化钾为主要成分的碱性去污剂进行清洗,能将有机物残留量降到最少。使用马弗炉高温加热也能达到相当的效果,这种方法最节省人力、但需要特定设备。
    总之,要证明采用的清洗方法适用于所要进行的具体检测和分析操作是非常必要的,我们可以通过空白试验、科学判断、清洁剂残留数据、清洁剂制造商或其他方法来做到这一点。此外,我们需要特别注意用于光学检测玻璃容器的清洗,应避免使用强碱性洗涤剂和已不再推荐使用的铬酸溶液。最后,清洗方案中应该包括如何判断清洁是否成功的说明。
    请专家指证

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  • myreebok

    第3楼2009/07/16

    文字很流畅,其实个人觉得,药典这种东西,自己能看懂就是好的翻译,如果让别人也能理解,那层次就更高了一层,

    songqingguo 发表:CLEANING GLASS APPARATUS
    Success in conducting many Pharmacopeial assays and tests depends upon the utmost cleanliness of the glassware apparatus used. For example, the accuracy of the assays of heparin sodium and vitamin B12 activity, as well as the pyrogen and total organic carbon tests, are particularly dependent upon scrupulously clean glassware.
    One effective method used in the past for cleaning glassware is the application of hot nitric acid. A second traditional method for removing organic matter that does not require heat is the use of a chromic acid–sulfuric acid mixture. However, the chromic acid wash is not recommended because of the hazardous and toxic nature of the material.
    Several safer alternatives, including the use of cleansing agents, such as trisodium phosphate and synthetic detergents, have proven highly useful, but require prolonged rinsing. It may be useful to rinse with diluted nitric or sulfuric acid prior to rinsing with water. This operation will facilitate removal of residual alkaline material.
    For optical measurements, special care is required for cleaning containers, but the use of both chromic acid and highly alkaline solutions should be avoided.
    Effective removal of organic matter is very important for testing pharmaceutical waters in accordance with the general test chapter Total Organic Carbon 643. It has been demonstrated that an alkaline detergent with potassium hydroxide as the primary ingredient* leaves the least amount of organic matter residuals. Heating in a muffle furnace produces comparable results and is the least labor-intensive procedure; however, it requires specialized equipment.
    In all cases, it is important to verify that the cleaning procedure is appropriate for the particular test or assay being undertaken. This can be accomplished via blank runs, scientific judgments, residuals data from cleansing agent and detergent manufacturers, or other controls. Specifically, special care is required for cleaning containers for optical measurement applications; the use of highly alkaline and the no longer recommended chromic acid solutions should be avoided. Finally, a statement should be included in the cleaning protocol describing how the success of the cleaning procedure will be assessed.

    〈1051〉玻璃器皿的清洁
    很多药典分析及检测方法的成功实施取决于所用玻璃仪器的绝对洁净度,如肝素钠含量和维生素B12活性检测的准确性,再比如热源和总有机碳检测更是特别需要洁净度高的玻璃器皿。
    热硝酸是过去经常使用的一种非常有效的清洗玻璃器皿的方法,另一种传统的用于洗涤有机物而又不需加热的方法是使用铬酸-硫酸混合液,但考虑到其自身的危险性及毒性,我们不推荐使用铬酸。
    其他可供选择的比较安全的清洗方法包括使用各种清洁剂,如磷酸钠及各种合成去污剂,这种方法是非常有效的,但其缺点是需要长时间的冲洗。在用水冲洗之前,先用稀硝酸或稀硫酸淌洗时非常有用的,这样可以有效地去除残留的碱性物质。
    我们需特别注意用于光学检测的玻璃容器的清洗,这里应避免使用铬酸和强碱性溶液。
    在检测药用水时,为与〈643〉部分总有机碳检测章节相符,(所用玻璃容器)有机物的除去就显得尤为重要,研究表明使用以氢氧化钾为主要成分的碱性去污剂进行清洗,能将有机物残留量降到最少。使用马弗炉高温加热也能达到相当的效果,这种方法最节省人力、但需要特定设备。
    总之,要证明采用的清洗方法适用于所要进行的具体检测和分析操作是非常必要的,我们可以通过空白试验、科学判断、清洁剂残留数据、清洁剂制造商或其他方法来做到这一点。此外,我们需要特别注意用于光学检测玻璃容器的清洗,应避免使用强碱性洗涤剂和已不再推荐使用的铬酸溶液。最后,清洗方案中应该包括如何判断清洁是否成功的说明。
    请专家指证

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  • 何当奇

    第4楼2009/07/16

    楼主翻译的非常好,欢迎楼主多发些这样高质量的原创翻译。

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  • ljzkevin

    第5楼2011/01/08

    挺好!谢谢楼主分享!

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