Storage conditions stability testing

Assignment of Climatic Zones and Recommended Storage Conditions Stability Testing Parameters for Different Dosage Forms... 

The storage conditions and the length of the studies should be sufficient to cover storage, shipment, and subsequent use. Both drug substances and products should be evaluated under storage conditions that test for thermal stability (temperature effect) and moisture sensitivity (humidity tolerance). 

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light, and enables recommended storage conditions, re-test periods and shelf lives to be established. 

Mittasch Stability Test for Nitrocellulose. A test based on the measurement of press developed on decompn of NC. The app may be considered a very complicated modification of devices originated by Abel (Ref 4, p 241) and Hess (Refs 1 4). Abel heated NC samples in vac and detd the press increase. Hess believed that on heating NC in a closed vessel contg air, connected to a Hg manometer, it would be possible to achieve conditions more closely resembling those in storage in closed magazines. Neither of these methods found any practical application... 

A solution to this dilemma is to place soil samples immediately in a freezer located in the field, the temperature of which is continuously monitored, as described previously. Laboratory-prepared storage study samples can then be used to determine test substance stability under freezer storage conditions that match those used in the field and during transportation and final storage. If a valid laboratory storage stability... 

The purpose of stability testing is to assess the effects of temperature, humidity, light, and other environmental factors on the quality of a drug substance or product. The data produced are used to establish storage conditions, retest periods, shelf loss, and to justify overages included in products for stability reasons. The most useful equation relating temperature and reaction rate is the Arrhenius equation. This equation (27) may be integrated and rewritten as Eqs. (31) and (32). 

Long-term testing Stability studies under the recommended storage condition for the retest period or shelf life proposed (or approved) are performed with several drug substance batches in the stipulate packaging. In the general case, the storage condition is at a temperature of 25°C and 60% relative humidity. 

Once the optimal formulation and processing method have been determined and the most suitable packaging configuration decided, product stability tests may be commenced. The aim is to determine a shelf life and provide data that demonstrate the product s continued quality under the conditions of manufacture, storage. 

If it is necessary to store test and control article mixtures, such materials should be stored entirely separately from animal housing areas. Special storage conditions (e.g., refrigeration and protection from light) must be available if needed to preserve and maintain the quality and stability of the mixtures. 

Labeling requirements in 58.105(c) are not controversial and are the minimum to ensure against mix-up of test or control articles. The Expiration date needs to be included on the label only if one has been established. Some laboratories include a retest date on the label as a reminder of the need for periodic stability analyses. Only special storage conditions (e.g., refrigerate, protect from light, protect from freezing ) need to be included on the label. 

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