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
Usually TLC is used for secondary ID. The variability for both TLC and HPTLC makes the validation harder. I do not recommend them for stability indicating methods; however, if you meet the ICH Q3A/B(R2) acceptance criteria, use them.
A general overview of drug stability testing is given by https://pdfs.semanticscholar.org/f4ea/36a3fe7c2f7c70e5a335d2259453a8993eee.pdf or by
https://www.japsonline.com/admin/php/uploads/409_pdf.pdf
As far as the methods to be used are concerned TLC or HPTLC are inferior to HPLC or UPLC. See for an overview of techniques used in pharmaceutical labs
Article Analytical techniques in pharmaceutical analysis: A review
More specific a setting up an HPLC method is found in http://ijpsr.com/bft-article/stability-indicating-hplc-method-development-a-review/?view=fulltext
Using of HPTLC as official methodologies in Register processes of drug substances and drug products. Thank you.
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