Storage Condition of Pharmaceutical Products
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.
There are also some definitions in the WHO Guidance:
- 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.
Read also: Different Types of Stability Studies in Pharmaceutical Industries
