Storage test conditions

Two plans are presented to assist applicants who desire to switch their approved drug products to the ICH-recom-mended storage conditions. Under each plan, recommendations will be made on how to initiate a switch to the ICH storage testing conditions, select batches, collect data, report results, and proceed if products fail the approved specifications under the ICH conditions. 

Products without an Approved Stability Protocol Applicants who have previously performed stability studies on a drug product without an approved protocol should submit an appropriate protocol as a Prior Approval Supplement. This protocol should contain 25°C/ambient humidity as the primary long-term storage testing conditions, and... 

Modem Dewar flask equipment includes an adiabatic shield, a compensation heater, and a computer to provide for control and for data acquisition and analysis. An example of the application of an advanced design is the adiabatic storage test (AST) [120,121]. In the AST, the heat generated at nearly adiabatic conditions by the reacting or decomposing substances is determined as a function of time. 

Surveys can still be useful since they integrate the outcome of all the factors along the entire supply chain to test predictions and assess whether models are taking the relevant factors into account, as well as generating new hypotheses when this is not the case. However, if done as isolated studies, the results of food quality surveys obtained at the point of sale have very little predictive power, unless extensive additional data are collected (e.g. origin, variety/breed, storage extent, conditions). Often this is not possible. 

The static heat treatments are carried out under iso-thermic conditions/40°,60°C/for longer periods of time /several weeks/,This can be considered an accelerated long term storage test. The thermal analyses of flavor cyclodextrin complexes and the corresponding adsorbates /cyclodextrin-flavor mixture with identical flavor content/indicate that the release of volatiles starts... 

Note All formulations should be subjected to storage tests under various temperature and humidity conditions. 

It is usual to divide the period before test into storage and conditioning where conditioning refers specifically to the process of bringing the test pieces to the required conditions of temperature and perhaps humidity immediately before test, and storage refers to the period before this back to the time of forming. 

Storage Tests. Steaks prepared using the processing conditions in Table IX were evaluated at intervals in a one-year room temperature (24°C.) storage test. One set of samples taken from a single U. S. Choice round was irradiated to 3.0 megarads at room temperature to serve as internal panel controls. These samples were held at 24°C. for 1 week and then placed in — 20°C. storage. 

The US and EU accelerated migration test conditions for long term ambient storage, 10 d at 49 °C and 10 d at 40 °C, yield equivalent migration values to those calculated in Example 14-3 for ambient storage at 23 °C for six months ... 

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