Tag: Assay Validation

Conduct Mass Balance Studies When Degradation Is Observed in Stability Data

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Understanding the Tip: What is a mass balance study in stability testing: Mass balance in the context of pharmaceutical stability refers to accounting for the drug’s original content by summing the remaining active ingredient and its measurable degradation products. When a product degrades, mass balance ensures that the reduction in assay corresponds reasonably to the…

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Stability Study Tips

Fully Validate Stability-Indicating Methods Before Use in Studies

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Understanding the Tip: What is a stability-indicating method: A stability-indicating method is an analytical procedure that accurately and specifically measures the active pharmaceutical ingredient (API) without interference from degradation products, excipients, or impurities. Its primary role is to detect changes in the chemical profile of the drug substance or product during stability studies, making it…

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Stability Study Tips