Official storage conditions of Pharmaceutical product as per defined by the USP (United StATE Pharmacopoeia) & IP (INDIAN Pharmacopoeia)
| Storage condition | As per USP |
|---|---|
| Cold | temperature not exceeding 8°C and refrigerator is a cold place where the temperature is maintained between 2 and 8°C. |
| Controlled Cold Temperature | temperature maintained thermostatically between 2° and 8°C. |
| Cool | any temperature between 8 and 15°C |
| Room Temperature (RT) | temperature prevailing in a working area |
| Warm | any temperature between 30 and 40°C |
| Excessive Heat | any heat above 40°C |
| Freezer | –25°C and –10°C. (Prepared by ThePharmapedia.com) |
| Protect from Freezing | in addition to the risk of breakage of the container, freezing subjects an article to loss of a product to a loss of strength, potency or to destructive alteration its characteristics, the container label should bear appropriate instructions to protect the product from freezing |
| Dry Place | denotes a place that does not exceed 40% average relative humidity (RH) at Controlled Room Temperature |
| Storage condition | As per IP |
|---|---|
| COLD | Any temperature not exceeding 8°C & usually between 2 and 8°C. |
| Cool | Any temperature between 8 and 25°C |
| ROOM TEMPERATURE | Temperature prevailing in a working area |
| Warm | Any temperature between 30 and 40°C |
| Freezer | -2° to -18° C |
| DEEP FREEZER | Below -18°C |
| DRY PLACE | Well-ventilated place at a temperature not exceeding 30° |
| Pharm. Eur. | WHO | USP | JP | |
| Frozen/ deep-freeze | >-15°C | -20°C | – | – |
| Refrigerator | 2°C – 8°C | – | – | – |
| Cold | 8°C – 15°C | 2°C – 8°C | <8°C | 1°C – 15°C |
| Cool | 8°C – 15°C | 8°C – 15°C | 8°C – 15°C | – |
| Room temperature | 15°C – 25°C | 15°C – 25°C | temperature prevailing in a work area | 1°C – 30°C |
| Controlled room temperature | – | – | 20°C – 25°C excursions between 15°C and 30°C are allowed | – |
| Ambient temperature | – | 15°C – 25°C or 30°C depending on climatic conditions | – | – |