What is freeze/thaw study?
Freeze-Thaw studies put products through a series of extreme temperature changes, the so-called freeze-thaw cycles. An example of a freeze-thaw cycle is exposing the product to freezing temperatures (approximately -15°C to -25°C) for 24 hours and then store it at a higher temperature (approximately 25°C) for 24 hours.
Which is correct ICH Guideline for stability study?
Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes.
When would you use accelerated stability studies?
accelerated stability testing Studies designed to increase the rate of chemical degradation and physical change of a drug by using exaggerated storage conditions as part of the formal stability testing programme.
How is a freeze/thaw test done and what does it determine?
Freeze-thaw cycle testing is a part of stability testing that allows you to determine if your formula will remain stable under various conditions. This type of test puts your sample through a series of extreme, rapid temperature changes that it may encounter during normal shipping and handling processes.
How long are freeze/thaw cycles?
Experimental results of the freeze-thaw cycles of tuff demonstrate that the freeze-thaw duration of the freeze-thaw cycles within 40 times can be set to 9 h. The freezing and melting processes are 6 and 3 h, respectively.
How many batches should be considered for in use stability?
A minimum of two batches, at least pilot scale batches, should be subjected to the test. At least one of the batches should be chosen towards the end of its shelf life. If such results are not available, one batch should be tested at the final point of the submitted stability studies.
How many ICH guidelines are there?
These five ISO standards not only meet the original ICH needs for electronic exchange of ICSRs in post-marketing pharmacovigilance, but also support broader functionality.
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