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【分享】药典中关于温度的定义

专业英语

  • 关于温度的定义,美国药典、欧洲药典和中国药典都有具体规定,但前者较后二者要详细些。

    欧洲药典仅列出了如下四项:

    -in a deep-freeze: below -15°C;

    -in a refrigerator: 2°C to 8°C;

    -cold or cool: 8°C to 15°C;

    -room temperature: 15°C to 25°C.

    中国药典也只列出了如下四项:

    阴凉处:系指不超过20°C

    凉暗处:系指避光并不超过20°C

    冷处:系指2-10°C

    常温:系指10-30°C
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  • 牛牛

    第1楼2010/08/10

    楼主的前者是指美国药典吗?如果是,又为何没有列出呢?

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  • 影子

    第2楼2010/08/10

    美国药典32版关于温度的一些定义:

    Freezer
    “Freezer” indicates a place in which the temperature is maintained thermostatically between -25°C and -10°C.

    Cold
    Any temperature not exceeding 8°C is “cold.” A “refrigerator” is a cold place in which the temperature is maintained thermostatically between 2°C and 8°C

    Cool
    Any temperature between 8°C and 15°C is “cool.” An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph.

    Controlled Cold Temperature
    “Controlled cold temperature” is defined as temperature maintained thermostatically between 2°C and 8°C, that allows for excursions in temperature between 0°C and 15°C that may be experienced during storage, shipping, and distribution such that the allowable calculated mean kinetic temperature is not more than 8°C. Transient spikes up to 25°C may be permitted if the manufacturer so instructs and provided that such spikes do not exceed 24 hours unless supported by stability data or the manufacturer instructs otherwise.

    Room Temperature
    “Room temperature” indicates the temperature prevailing in a working area.

    Controlled Room Temperature
    “Controlled room temperature” indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20°C to 25°C; that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15°C and 30°C that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours. Spikes above 40°C may be permitted if the manufacturer so instructs. Articles may be labeled for storage at “controlled room temperature” or at “up to 25°C”, or other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations.
    An article for which storage at controlled room temperature is directed may, alternatively, be stored and distributed in a cool place, unless otherwise specified in the individual monograph or on the label.

    Warm
    Any temperature between 30°C and 40°C is “warm.”

    Excessive Heat
    “Excessive heat” means any temperature above 40°C.

    Protection From Freezing
    Where, in addition to the risk of breakage of the container, freezing subjects an article to loss of strength or potency, or to destructive alteration of its characteristics, the container label bears an appropriate instruction to protect the article from freezing.

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  • 影子

    第3楼2010/08/10

    你的沙发抢得太快了的

    牛牛(wozhuanyong) 发表:楼主的前者是指美国药典吗?如果是,又为何没有列出呢?

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  • 916067561

    第4楼2011/02/10

    能否总结一下美国药典关于温度的主要内容

    影子(hyheying) 发表:美国药典32版关于温度的一些定义:

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  • 影子

    第5楼2011/02/10

    上面的应该就是啊,还需要怎样的总结呢?

    916067561(916067561) 发表:能否总结一下美国药典关于温度的主要内容

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