Forced Degradation Studies

The Forced Degradation Studies category provides in-depth scientific insights, regulatory guidance, and advanced analytical strategies for pharmaceutical degradation profiling. This section is designed for formulation scientists, QA/QC professionals, regulatory teams, and CDMOs/CROs seeking authoritative knowledge on stress-testing methodologies used to evaluate drug substance and drug product stability.

Forced degradation—also known as stress testing—is a critical component of pharmaceutical development and ICH Q1A(R2) stability guidelines. Blogs in this category explore the design and execution of degradation pathways under acidic, basic, oxidative, thermal, and photolytic stress conditions to identify potential degradation products and understand API susceptibility. You will also find expert content on LC-MS/MS structural elucidation, impurity profiling workflows, mass-balance verification, and method robustness considerations.

At ResolveMass Laboratories, our goal is to demystify complex degradation mechanisms while highlighting scientifically rigorous approaches for unknown impurity identification, method development, validation, and regulatory submission readiness. Whether you are optimizing formulation stability or preparing for NDA/ANDA filings, this category will help you navigate both the experimental and regulatory dimensions of forced degradation studies with clarity and confidence.

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