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Euglocon 5mg: Glibenclamide Source Update by mccenteno is a document available to read on EtoBox.

What is Euglocon 5mg: Glibenclamide Source Update about?

The document proposes an alternative source for glibenclamide, the active ingredient in Euglucon 5mg tablets. It performs a risk assessment by comparing the new material to the existing specifications, evaluating that the new material could negatively impact product assay but would not change the formulation or manufacturing process. Stability studies are recommended to determine the actual impact on product stability as the worst case risk. Process validation of Euglucon tablet manufacturing and revalidati

Author

mccenteno

Language

EN