In house Reference Std and EDQM Reference Std

Initially FP Manufacturer used IH Ref Std (Hemipentahydrate form) for validation batches and then EDQM Ref. Std (Heptahydarte form) became official, FP Manufacturer started using Heptahydrate form ref. Std for routine batch release.

Please confirm what is the impact and what documents should i ask from manufacturer for regulatory submission

Stucter characterisation data should be required


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