RE: Purpose of API stability study
Contribution from Venkat written on 4/11/2012 at 15:04
Original contribution: Purpose of API stability study written by Arun David on 4/11/2012 at 11:17)
The purpose of stability testing is to provide evidence on how the quality of a drug substance varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance and recommended storage conditions.
Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.
Examining degradation products under stress conditions is useful in establishing degradation pathways and developing and validating suitable analytical procedures. However, it may not be necessary to examine specifically for certain degradation products if it has been demonstrated that they are not formed under accelerated or long term storage conditions.
Results from these studies will form an integral part of the information provided to regulatory authorities.
For detailed information, refer ICH Q1A (R2) guidelines please...
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