Refrigerator storage statements

For a drug product demonstrated to be stable at 5° 3°, 2°-5°, or 2°-8°C with or without humidity control and that is intended to be stored at refrigerator temperature, the recommended storage statement for labeling may be one of the following ... 

For a drug product demonstrated to be stable both at 25° 2°C/60% RH + 5% and at refrigerator temperature, both of the room temperature and refrigerator labeling statements, as described above, are acceptable, depending on the storage conditions intended for the product. A statement such as store at 2°-25°C is not recommended. 

We now come to three doubtful reasons, in particular the view that low temperatures are beneficial processing conditions. It will be shown in Chapter 5 that such a statement needs careful qualification it is certainly not a universal truth. As to the quality of the freeze-dried products, here again questions arise. Product catalogues distributed by manufacturers of biochemicals bear witness to apparent doubts about quality, because the need for refrigerated storage is usually specified and, for many biopharmaceutical products, deep frozen storage is apparently an absolute requirement. If this is indeed the case, then the slow removal of ice from the frozen solution by sublimation is surely superfluous. A simple freeze-thaw process would suffice. 

The formerly used Keep cool has disappeared from the list. Cold or cool is defined by the Ph. Eur. as 8-15 °C. A statement like that would not make much sense to the patient any more, as most people do not have the possibility of storage in a cool place. When large quantities of products have to be kept on stock in a pharmacy however, a cool place could be more convenient than a refrigerator. In those cases the pharmacist should decide how long the shelf life can be under these conditions (see Sect. 22.5.7). 

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