Validation question

Discussions about methods, troubleshooting and best practices across both pharmaceutical and biopharmaceutical analysis.

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Hi, I am validating a stability indicating HPLC method for assay and impurities for both drug substance and drug product. All impurities listed in the drug substance and drug product specifications are the same and their criteria are the same.

Can I only validate spiked recovery for impurities in drug product which I think is the worst case scenario and waive the spiked recovery for impurities in drug substance?

Thanks.
You can use this approach with justification. However, be prepared to defend your approach in audits. TBH, I would just perform separate validation for DP and DS.
2 posts Page 1 of 1

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