Hey guys! Nice to meet you. This is Andre, from Brazil and I'm really curious about the uses of TLC and HPTLC as official methodologies in Register processes of drug substances and drug products.
For your regulatory agencies, how is their understanding about this subject?
Do they take kindly to this kind of approach?
In practice, do you use this kind of methodology for related substances and degradation products in lab routine? And for stability assays?
My best regards! #drug #stability #regulatory #lab #CQ #pharmaceuticalsciences
Rowell nailed that answer exactly! It depends where you (regulations) are and what method you have. Please keep in mind that the "right" thing to do is not always about what the regulators want. It is also about developing and using proper scientific techniques to back up any claims made.
Yes you can make TLC or HPTLC as standard method to indicate drug stability. Just make sure method is validated and the procedure is repeatable.
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