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性别保密
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发表于 2013-9-9 15:40:06
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中国药典中没有规定
USP中是有的
可以作为参考
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.
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