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

Post a Comment

Previous Post Next Post