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Govind Shinde

Sep 2026 • linkedin

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1.What is Forced Degradation Study? Forced degradation study is a stress-testing study in which a drug substance (API) or drug product is intentionally exposed to different stress conditions. The purpose is to produce degradation products/impurities and understand how the drug behaves under stress. The most important objective is to demonstrate that the analytical method, such as HPLC, can separate the API peak from degradation peaks. Therefore, the method can be considered a stability-indicating method. 2. Select…

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