Stability testing drug development

Drug substance/drug product purity, potency, and other testing Drug substance/drug product stability testing Method development, validation, and transfer Drug product formulation development... 

In summary, TLC analysis plays a critical role in the drug development process. Many instruments are available, and the technique is used for both quantitative and qualitative testing. i f determination, identity testing, and stability testing are just a few ways to utilize TLC. 

B. Stability Testing at Different Phases of the Drug Development Process... 

CE methods are developed and utilized in pharmaceutical QC for early to late phases of drug development. Chapter 4 covers the approaches for late-phase development for small molecules that can be used in early-phase development, as well as for large-molecular-weight compounds. Late-phase method development in pharmaceutical QC is performed for required stability studies and for release of the drug product or drug substance validation batches, and is intended to be transferred to the operational QC laboratories for release testing of the production batches. Preferably, late-phase methods should be fast, robust, reliable, and transferable. Therefore it is crucial to devote adequate time, thought, and resources to the development of such methods. 

Grimm W. A rational approach to stability testing and analytical development for NCE, drug substance, and drug products marketed product stability testing. In Carstensen JT, Rhodes CT, eds. Drug Stability Principles and Practices, 3rd edn. New York Marcel Dekker, 2000 415-81. 

Stress testing is an important part of the drug development process as it provides knowledge about the degradation chemistry of drug compounds. This knowledge is used primarily to develop stability-indicating analytical methods but is also useful for other purposes such as formulation develop-... 

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