If we have 5 strength which is not dose proportinate and excipients also diffrent in each strength then how we can proceed for Force degradation? and excipient are same but not dose propotinate the how FD?
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Answer Posted / Varun Kumar Sharma
Forced degradation (FD) is a method used to intentionally degrade a drug substance or product under stress conditions to study its stability and degradation pathways. When dealing with multiple strengths of a drug product with non-proportional doses, you can perform FD by exposing each strength to the same stress conditions (like heat, light, pH extremes, etc.) individually. For excipients that are not dose proportional, their behavior during FD can be studied separately, and any potential impact on the drug substance's degradation can be assessed.
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