不超过多少度规定中 下限是多少度

woaichenog

如题......

可亲可爱

你的都 什么多少度？温度吗？

woaichenog

可亲可爱 发表于 2021-4-23 10:19
你的都 什么多少度？温度吗？

温度， 仓库的

ning1018

没头没尾

ejckuo

USP 40 <659> Packaging and Storage Requirements

TEMPERATURE AND STORAGE DEFINITIONS

Freezer: A place in which the temperature is controlled between -25° and -10° (-13° and 14° F). It is noted that, in some instances, articles may have a recommended storage condition below -20° (-4° F). In such cases, the temperature of the storage location should be controlled to ±10°.

Refrigerator: A cold place in which the temperature is controlled between 2° and 8° (36° and 46° F).

Cold: Any temperature not exceeding 8° (46° F).

Cool: Any temperature between 8° and 15° (46° and 59° F). [NOTE—An article for which storage in a cool place is directed may, alternatively, be stored and shipped as refrigerated, unless otherwise specified by the individual monograph.]

Room temperature (also referred to as Ambient temperature): The temperature prevailing in a working environment.

Controlled room temperature: The temperature maintained thermostatically that encompasses the usual and customary working environment of 20°–25° (68°–77° F). The following conditions also apply.
Mean kinetic temperature not to exceed 25°. Excursions between 15° and 30° (59° and 86° F) that are experienced in pharmacies, hospitals, and warehouses, and during shipping are allowed. Provided the mean kinetic temperature does not exceed 25°, transient spikes up to 40° are permitted as long as they do not exceed 24 h. Spikes above 40° may be permitted only if the manufacturer so instructs.
Articles may be labeled for storage at “controlled room temperature” or at “20°–25°”, or other wording based on the same mean kinetic temperature [see also Good Storage and Distribution Practices for Drug Products <1079>, Quality Management System, Mean Kinetic Temperature (MKT) Calculation]. An article for which storage at Controlled room temperature is directed may, alternatively, be stored and shipped in a cool place or refrigerated, unless otherwise specified in the individual monograph or on the label.

Warm: Any temperature between 30° and 40° (86° and 104° F).

Excessive heat: Any temperature above 40° (104° F).

Dry place: A place that does not exceed 40% average relative humidity at 20° (68° F) or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place. Determination is based on NLT 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 does not exceed 40% relative humidity. Storage in a Container validated to protect the article from moisture vapor, including storage in bulk, is considered a Dry place.

Protect from freezing: The Container label will bear an appropriate instruction to protect the article from freezing in cases where freezing exposes an article to loss of strength or potency or to destructive alteration of its characteristics. These risks are present in addition to the risk that the Container may break if exposed to freezing temperatures.

Protect from light: Where light 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 light. The article must be packaged in a light-resistant Container.

一只小猪

是温度还是啥

北重楼

问题是啥？？？

ft830614

是指阴凉库不超20度那种么？正常情况下没有没有规定，常温库才有区间要求。

woaichenog

北重楼 发表于 2021-4-23 12:49
问题是啥？？？

看到之前的指南的截图，标签温度是‘≤25℃’的，温度是指2℃至25℃。但找不到这个指南了，平时也没注意到这类标识有温度下限，所以有此一问。 问题没写太清楚

woaichenog

ft830614 发表于 2021-4-23 13:33
是指阴凉库不超20度那种么？正常情况下没有没有规定，常温库才有区间要求。

是，看到一个指南截图，说的是标签储存条件是‘≤25℃’的，温度范围是2-25℃，但找不到指南原文了。

woaichenog

ejckuo 发表于 2021-4-23 10:58
USP 40  Packaging and Storage Requirements

TEMPERATURE AND STORAGE DEFINITIONS

假如 储存条件是 ≤25℃， 这个条件有下限的要求么？

小金库

学习借鉴，感谢楼主