Temperature Limits


(Jalindar Anap) #1

What are the limits for,
Room Temperature, Ambient temperature, cool temperature, cold temperature?


(Ankur Choudhary) #2

Please go through following link


(Bhavani) #3

What is ambient temperature?


(Ravi) #4

ambient temperature is the actual temperature of the air in any particular place, as measured by a thermometer. It may be very different from usual room temperature, for example an unheated room in winter.


(Sabbineni) #5

Ambient temperature means Room temperature i.e 25deg cent.


(Gaurav Dwivedi) #6

USP has some references. “Packaging and Storage Requirements” gives various examples for different storage conditions, for example:
Cold: Any temperature not exceeding 8°C (46 °F).
Cool: Any temperature between 8° and 15° (46° and 59 °F)
Room temperature: The temperature prevailing in a work area.
Controlled room temperature: The temperature maintained thermostatically that encompasses at the usual and customary working environment of 20°-25° (68°-77 °F). 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.
Warm: Any temperature between 30° and 40°C (86° and 104 °F).
Excessive heat: Any temperature above 40° (104 °F).

The European Pharmacopoeia (Pharm.Eur.) gives some hints in chapter 1.2 (Other provisions applying to general chapters and monographs) with referring to analytical procedures:
Deep-freeze: below -15°C;
Refrigerator: 2°C to 8°C;
Cold or cool: 8°C to 15°C;
Room temperature: 15°C to 25°C.

WHO defined:
Store frozen: transported within a cold chain and stored at -20°C (4°F).
Store at 2°-8°C (36°-46°F): for heat sensitive products that must not be frozen.
Cool: Store between 8°-15°C (45°-59°F).
Room temperature: Store at 15°-25°C (59°-77°F).
Ambient temperature: Store at the surrounding temperature. This term is not widely used due to significant variation in ambient temperatures. It means “room temperature” or normal storage conditions, which means storage in a dry, clean, well ventilated area at room temperatures between 15° to 25°C (59°-77°F) or up to 30°C, depending on climatic conditions.