Forced Degradation Studies for Drug Substances & Drug Products- A Regulatory Considerations

by Rohit T. Veeprho Laboratories Pvt.Ltd

Various regulatory guidance is available which provides useful definitions and general comments about degradation studies. However, guidance concerning the scope, timing, degradation condition, and best practices for degradation studies is very general. Various issues related to stress testing are addressed in numerous guidance documents but not always in the context of stress testing. Therefore, stress-testing conditions should be realistic and not excessive.

Forced degradation studies are also expected –

Structure elucidation of possible degradation pathways.
Identification of degradation products that may be spontaneously generated during drug storage and during use.
To facilitate improvements in the manufacturing process and formulations in parallel with accelerated pharmaceutical stability studies.

Overview of regulatory authorities –

ICH Q1A – Testing of stability for new drug molecules and their products

The intrinsic stability of drugs is determined using these guidelines. These guidelines are helpful in designing methods for determining the stability of drugs. According to Q1A, degradation depends on the respective drug molecules and the nature of drug products. To conduct these forced decomposition analyses on drug substances and their products several accelerated conditions were mentioned. Those conditions include the effects of temperature (>40°C), humidity (≥75% relative humidity), oxidation, photolysis, and diverse range of pH (solution/suspension).

ICH Q1B – Photostability testing of new drug substances and drug products

These methods are used to estimate the photostability nature of drug molecules normally in the development stage. These guidelines provide knowledge about how to assess the photostability of molecules that are under study for stability studies.

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