Freezer “Freezer” indicates a place in which the temperature is maintained thermostatically between -25°C and -10°C.
Cold Any temperature not exceeding 8°C is “cold.” A “refrigerator” is a cold place in which the temperature is maintained thermostatically between 2°C and 8°C
Cool Any temperature between 8°C and 15°C 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.
Controlled Cold Temperature “Controlled cold temperature” is defined as temperature maintained thermostatically between 2°C and 8°C, that allows for excursions in temperature between 0°C and 15°C that may be experienced during storage, shipping, and distribution such that the allowable calculated mean kinetic temperature is not more than 8°C. Transient spikes up to 25°C 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.
Room Temperature “Room temperature” indicates the temperature prevailing in a working area.
Controlled Room Temperature “Controlled room temperature” indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20°C to 25°C; that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15°C and 30°C that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours. Spikes above 40°C may be permitted if the manufacturer so instructs. Articles may be labeled for storage at “controlled room temperature” or at “up to 25°C”, 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. 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°C and 40°C is “warm.”
Excessive Heat “Excessive heat” means any temperature above 40°C.
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.
我的社区
签到
赛默飞实验室产品焕新计划有奖调研！
【七月征文】不一YOUNG实验“猿”
报名开启：ICS2024第十三届光谱网络会议！
推荐收藏！盘点中药材及饮片检测解决方案
