【求助】关于中国药典凡例中的温度，该如何理解？

飞凌大圣

关于中国药典凡例中的温度，该如何理解？

某蒲友问：
中国药典2020年版凡例中，对于温度的表述是这样的（见下图）：
1、阴凉处            系指不超过20℃；
2、冷处               系指2-10℃；
3、常温（室温）  系指10-30℃。

那么问题来了：
（1）10℃算什么条件，常温？阴凉？还是冷处？
（2）阴凉处是不超过20℃，没有下限要求，那么10℃、2℃、0℃及以下也算阴凉吗？
（3）如果说阴凉处的温度是10-20℃，那么室温设置10-30℃是否就不合理了，应该是20-30℃才对？

欢迎大家积极讨论，谢谢！

咒逐

我认为这就是个简单的鸡生蛋问题。我们确定某房间温度难道不应该是先给这个房间定性吗？定性是阴凉，那么只要10℃符合就可以了呀。不管你10还是2还是0，符合，就行了。是房间给温度定性，就不该是温度给房间定性。

来自苹果APP客户端

冬天的朵儿

根据设定的条件，测定或者设定温度的。10摄氏度也没什么好纠结的，条件写阴凉处和常温，都在范围内算合格的

来自安卓APP客户端

依雪轻寒

个人觉得，不必教条，可以根据实际情况设定在这个范围内就行，有时太认真也很苦恼

凌云显扬

个人认为：10℃不需要一定给他归属到某一个条件下，只要满足你药品储存条件即可，例如：某药品在20℃、10℃、及5℃这三个温度点都是稳定，超过20℃以上不太稳定，那我选择一个药品储存条件，选常温（室温）、冷处就都不太满足我的条件，这样我就可以将药品条件定为阴凉。

nmtul

根据样品储存条件定

hongwei2000

你的理解有问题
反着去理解肯定是错误的
例如说专人
不是指这个人只做这件事
而是这件是只能由这个人来做
温度也是一样的道理
不是哪一个温度是什么温区
而是某个温区应控制在什么范围
不过冷藏和阴凉药典委一直是死猪的状态
没有一点改的想法
例如2-8度是明确在GSP里面要求的
而阴凉一般常规人的理解也不能是冻上的
它们却死也不改

光风霁月

ChP中关于温度和储存定义不太明确的话，可以参考USP-NF 659 Packaging and Storage Requirements。USP-NF 659关于Temperature and Storage Definitions如下：

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°▲ of the recommended storage condition▲ (USP 1-Dec-2020).

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 cold temperature: The temperature maintained thermostatically between 2° and 8° (36° and 46° F), which allows for temperature excursions between 2° and 15° (36° and 59° F) that may be experienced during storage, shipping, and distribution, but not to exceed 24 h, such that the allowable calculated mean kinetic temperature (MKT) is NMT 8° (46° F) with no excursions below 2° (36° F) or above 15° (59° F). These limits (time and temperature) and the calculated MKT must be documented (see Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products á1079.2ñ). Additionally, controlled cold excursions may only occur one time during the possession of the product within59° F) should be supported by stability data. Other limits may be permitted if the manufacturer so instructs as supported by the manufacturer’s stability data and/or thermal cycling studies.▲ (USP 1-Dec-2020)

Controlled room temperature: The temperature maintained thermostatically that encompasses the usual and customary working environment of 20°–25° (68°–77° F).
▲MKT may be used during an excursion provided: 1) MKT does not exceed 25° (77° F); 2) excursion between 15° and 30° (59° and 86° F); 3) transient excursions are NMT 40° (104° F); and 4) excursion time is NMT 24 h.2 These limits (time and temperature) and the calculated MKT must be documented.▲ (USP 1-Dec-2020)
Articles may be labeled for storage at “controlled room temperature” or at “20°–25°”, or other wording based on the same MKT. ▲(See á1079.2ñ.)▲ (USP 1-Dec-2020)

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. ▲Storage time in controlled cold
or cool place cannot be used to calculate excursion temperature outside of controlled room temperature ranges.▲ (USP 1-Dec-2020)

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.

▲Do not refrigerate: The Container label will bear an appropriate instruction to protect the article from refrigeration in cases where refrigeration exposes the article to loss of strength or potency or destructive alteration of its characteristics (e.g.,
precipitation, cloudiness). These risks are increased when a drug product with the storage temperature of 20°–25° (68°–77° F) is formulated at near-maximum solubility.▲ (USP 1-Dec-2020)

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.

houzifan

个人理解：阴凉处， 系指不超过20℃。应该为特定环境中的最差条件，比如夏天，为了节约成本有一部分企业可能达不到这个要求。
对于这个常温10-30℃也是倍感无语，我们这到了冬天，2℃-3℃经常出现，0℃的情况也非常多，像这种情况，我们这些小企业如果跟老板说，
温度不符合规定，要升温到10℃以上，明显不现实；在一次检查中检查员也发现了我们这个问题，他说“像这种情况你们应该评估一下，这个温度会不会对物料产生影响”。
个人总结为：只要不超过规定的上限，下限的话只要别太离谱，没必要纠结这个问题（某些特殊要求的产品除外）。