Parent only. Chiral assay? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-12-05 23:26  – Posting: # 20935
Views: 392

Hi ElMaestro & Elena777,

@Elena777: 1) according to the GL. Full stop.

» my recent experience in EU is that they tend to ask for the parent, and only the parent, if this can be measured (and if systemically acting blah blah).

@ElMaestro: Agree. Guideline =  cookbook  holy book nowadays.

» There is also some regulatory wobble regarding enantiomers. Sometimes they ask for a chiral assay,……

Really? Happened to me only once in 2010 though the other way ’round.

» … and sometimes they don't and their choice seems not to always follow the formal criteria criteria stated in the guideline. I haven't cracked the code yet, but Hötzi has a good story about it from the horse's mouth. :-D
» Hötzi, over to you...

Aye, capt’n!
Nothing to add to this one. In the meantime we have almost 70 APIs covered in product-specific guidances. In none a chiral assay is recommended.

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Cheers,
Helmut Schütz
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