主题：【求助】USP中所指的常温是多少度

25±2℃

在USP药典中（PRESERVATION, PACKAGING, STORAGE, AND LABELING），是如下进行定义的，
The conditions are defined by the following terms.
Freezer— A place in which the temperature is maintained thermostatically between 25 and 10 (13 and 14 F).
Cold— Any temperature not exceeding 8 (46 F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 and 8 (36 and 46 F).
Cool— Any temperature between 8 and 15 (46 and 59 F). 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.
Room Temperature — The temperature prevailing in a working area.
Controlled Room Temperature — 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 .)
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.
Warm— Any temperature between 30 and 40 (86 and 104 F).
Excessive Heat— Any temperature above 40 (104 F).
Protection from Freezing— 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.
Dry Place— 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.

中国药典中的规定是，室温为10-30C，只有在温度对试验有影响时，采用25±2C

ICH规定，长期稳定性测定中，用的是25±2C，RH60±5%

一般是指25度

原文由 cjg691622 发表:
一般是指25度

同意。中国药典中的旋光度和相对密度都要求在20度测定，美国药典这两个项目要求在25度。

对不起呦，唉，这边似乎都是做药检分析的，太专业了!

重新学习了下，在USP TESTS AND ASSAYS 通则里，提到：

Temperatures— Unless otherwise specified, all temperatures in this Pharmacopeia are expressed in centigrade (Celsius) degrees, and all measurements are made at 25. Where moderate heat is specified, any temperature not higher than 45 (113 F) is indicated. See Storage Temperature under Preservation, Packaging, Storage, and Labeling for other definitions.

BTW,问下，这边有做产品国际注册的吗？在哪个版块呀？

原文由 ghost555 发表:
对不起呦，唉，这边似乎都是做药检分析的，太专业了!

重新学习了下，在USP TESTS AND ASSAYS 通则里，提到：

Temperatures— Unless otherwise specified, all temperatures in this Pharmacopeia are expressed in centigrade (Celsius) degrees, and all measurements are made at 25. Where moderate heat is specified, any temperature not higher than 45 (113 F) is indicated. See Storage Temperature under Preservation, Packaging, Storage, and Labeling for other definitions.

BTW,问下，这边有做产品国际注册的吗？在哪个版块呀？

什么产品国际注册？药品吗？happy做这个的吧