主题：【分享】美国药典和中国药典贮存条件的区别

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查看了一下，中国药典和欧洲药典对“干燥处”都没有详细的规定,只有美国药典上有:
10.30.100. Dry Place
The term “dry place” denotes a place that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value is 40% relative humidity.
Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered storage in a dry place.

原文由 hyheying 发表:
查看了一下，中国药典和欧洲药典对“干燥处”都没有详细的规定,只有美国药典上有:
10.30.100. Dry Place
The term “dry place” denotes a place that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value is 40% relative humidity.
Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered storage in a dry place.

请大家给我翻译的10.30.100.dry place 挑挑错吧
10.30.100. 干燥处Dry Place
干燥处指在控制的室温下平均相对湿度不超过40%，，或者在其他温度下与40%相当的水蒸气压力。湿度的测定应在实地直接测定，或根据报告的气候条件。至少要进行12次平行的实地测定，测定时间段为一个季度、一年，或者药品的贮存期限。如果平均相对湿度为40%，那么相对湿度可能达到45%。
贮存于经过验证的防潮容器的药品，包括大量贮存药品，应贮存在干燥处。

原文由 summer0751 发表:

请大家给我翻译的10.30.100.dry place 挑挑错吧
10.30.100. 干燥处Dry Place
干燥处指在控制的室温下平均相对湿度不超过40%，，或者在其他温度下与40%相当的水蒸气压力。湿度的测定应在实地直接测定，或根据报告的气候条件。至少要进行12次平行的实地测定，测定时间段为一个季度、一年，或者药品的贮存期限。如果平均相对湿度为40%，那么相对湿度可能达到45%。
贮存于经过验证的防潮容器的药品，包括大量贮存药品，应贮存在干燥处。

翻译得不错，只是对not less than 12 equally spaced measurements这句话有点小疑问，我觉得应该说明每次平行测定的时间间隔要一样。比方说，一个季度内我想进行12次平行测定，那么应该每隔7天测定一次，而不是将所有的测定都放在某一个月集中进行。

欧洲药典也列一下呢

原文由 waterina 发表:
欧洲药典也列一下呢

在欧洲药典中只看到了这个：
In a deep-freeze: below -15℃
In a refrigerator: 2℃ to 8℃
Cold or cool: 8℃ to 15℃
Room temperature: 15℃ to 25℃

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谢谢分享，了解一下各国法规

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