2024年3月21日发(作者：剪贴板怎么打开)

CP 中国药典

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。

除另有规定外，贮藏项下未规定贮藏温度的一般系指常温。

EP欧洲药典

Temperature. Where an analytical procedure describes temperature without a figure, the

general terms used have the following meaning:

温度：如分析程序中所规定的温度无具体描述，通常使用的术语的含义如下所示：

– in a deep-freeze: below − 15 °C; 低温冷冻：− 15°C以下

– in a refrigerator: 2 °C to 8 °C; 冷藏柜中 2-8°C

– cold or cool: 8 °C to 15 °C; 冷却：8-15°C

– room temperature: 15 °C to 25 °C. 室温：15 °C to 25 °C

USP美国药典

10.30. Storage Temperature and Humidity

10.30.贮藏的温度和湿度

Specific directions are stated in some monographs with respect to the temperatures and

humidity at which official articles shall be stored and distributed (including the shipment of

articles to the consumer) when stability data indicate that storage and distribution at a lower or a

higher temperature and a higher humidity produce undesirable results. Such directions apply

except where the label on an article states a different storage temperature on the basis of

stability studies of that particular formulation. Where no specific storage directions or limitations

are provided in the individual monograph, but the label of an article states a storage temperature

that is based on stability studies of that particular formulation, such labeled storage directions

apply. (See also Pharmaceutical Stability 〈1150〉.) The conditions are defined by the following

terms.

当稳定性数据表明药品在一个较低或较高的温度和高湿度的条件下贮藏与分发会造成

不良的后果，在一些各论中对于药典药品的贮藏和分发（包括发到客户的装运）的温度和湿

度有具体说明。除非基于特定配方的稳定性研究，在药品标签上标示了不同的贮藏温度，否

则上述说明均适用。如在各论中对贮藏没有具体的规定和限制，但基于特定配方的稳定性研

究，在药品标签上标示了贮藏温度，则适用标记的贮藏温度。（另见药品的稳定性〈1150〉）

用以下术语表示：

10.30.10. Freezer 冷冻区

“Freezer” indicates a place in which the temperature is maintained thermostatically

between −25° and −10° (−13° and 14°F).

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冷冻库指恒温维持在-25℃～ -10℃（-13-14℉）的地方

10.30.20. Cold 冷藏室

Any temperature not exceeding 8° (46°F) is “cold.” A “refrigerator” is a cold place in which

the temperature is maintained thermostatically between 2° and 8° (36° and 46°F).

温度≦8° (46°F)为冷，冷藏区表求自动控制温度维持在2° ～ 8° (36° and 46°F).

10.30.30. Cool 凉

Any temperature between 8° and 15° (46° and 59°F) 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.

温度在8° and 15° (46° and 59°F)称为凉。除非在具体各论中另有规定，规定贮藏于阴凉

处的药品也可以在冷藏室中贮藏和分发。

10.30.40. Controlled Cold Temperature 控制冷温

“Controlled cold temperature” is defined as temperature maintained thermostatically

between 2° and 8° (36° and 46° F), that allows for excursions in temperature between 0° and

15° (32° and 59° F) that may be experienced during storage, shipping, and distribution such that

the allowable calculated mean kinetic temperature is not more than 8° (46° F). Transient

spikes up to 25° (77° F) 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.

受控冷藏表示温度自动控制在2-8℃（36-46℉）。在贮藏、运输、分销的短期过程中允许

温度可在0-15℃（32-59℉）之间波动，可允许的动力学平均温度不能超过8℃（46℉）。如

果制造商有说明，短时间内超过25° (77° F)也是允许的，但不得超过24小时，除非有稳定性

数据支持或制造商有明确说明。

10.30.50. Room Temperature 室温

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

室温是指工作区域内的常用的温度。

10.30.60. Controlled Room Temperature 控制室温

“Controlled room temperature” indicates a temperature maintained thermostatically that

encompasses the usual and customary working environment of 20° to 25° (68° to 77°F); that

results in a mean kinetic temperature calculated to be not more than 25°; and that allows for

excursions between 15° and 30° (59° and 86°F) that are experienced in pharmacies, hospitals,

and warehouses. Provided the mean kinetic temperature remains in the allowed range,

transient spikes up to 40° are permitted as long as they do not exceed 24 hours. Spikes above

40° may be permitted if the manufacturer so instructs. Articles may be labeled for storage at

“controlled room temperature” or at “up to 25°”, 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. (See also Pharmaceutical Stability 〈1150〉.)

控制室温指一般工作环境中恒温维持在20-25℃（68-77℉），所引起的平均动力学温度不

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得超过25℃。在药企、医院和仓库中短途运输可允许的温度范围为15-30℃（59-68℉）。如

果温度的波动保持在可允许的范围内，最高温度可达40℃，只要它不超过24小时。如果生

产商有所说明，最高温度在40℃以上，也是被允许的。药品可以标示为“控制室温下贮藏”、

“25℃以下贮藏”或其基于相同的平均动力学温度的措辞。平均波动温度是一个计算值，它

是用于恒温贮藏中模拟变化的贮藏温度的非等温效应（也可见于药品稳定性1150）。

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.

药品规定贮藏于受控温度下时，等同于在凉处贮藏与分发。除非在独立专论或标签上有

另外说明。

10.30.70. Warm 暖/温

Any temperature between 30° and 40° (86° and 104°F) is “warm.”

温/暖系指30～40℃（86～104℉）

10.30.80. Excessive Heat 过热

“Excessive heat” means any temperature above 40° (104°F).

过热系指 温度高于40℃（104℉）。

10.30.90. Protection From Freezing 防冻

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.

如除容器破损的风险外，冷冻会导致药品效力和效价变差、或者性状发生破坏性变化，

则容器标签须有合适标示，以防药品受冻。

10.30.100. Dry Place 干燥处

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.

干燥处系指在受控室温下，平均相对湿度不超过40%，或者是在其他温度下，不超过相等

的水蒸气压。

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.

测定可直接实地测量或根据气候条件的报告。测定应基于至少12个等间隔的测量，可以

季度，年为间隔时间，如有记录数据证明，以药品存储期为间隔时间。

There may be values of up to 45% relative humidity provided that the average value is 40%

relative humidity.

如相对湿度平均值为40%，相对湿度可能达到45%。

Storage in a container validated to protect the article from moisture vapor, including storage

in bulk, is considered storage in a dry place.

将产品储存于经过验证的容器中，以防止潮湿，包括大宗物料的贮藏，都被认为是贮藏

于干燥处。

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