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储存条件“干燥”相关规定

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风清飞扬 二阶会员 用户来自于: 广东省深圳市
2020-08-08 09:30

USP 凡例中10.保存,包装,储藏和标签中有关于干燥处的规定。

10.30.储存温度和湿度

10.30.100.干燥处

Dry Place-The "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.

“干燥处”一词表示一个地方在控制的室温下其水分不超过40%,或者在其它温度下不超过等价的水蒸汽压。测定可能是实地直接测量或者报告的气候条件。记录数据表明,产品的储存时间测定应为不少于12次的等距测定包括每季,每年。这里的相对湿度可能高达45%,平均相对湿度的平均值为40%。

Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered a dry place.

将产品储存在已验明可以防止水汽进入的容器内,包括大批量的储存,也必须储存在干燥处。




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发布时间
2020-08-07 12:02
更新时间
2020-08-08 09:54
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