Vitamins Guidance

[an_k]

Does someone can provide information about vitamins guidance (in order to set impurities specs…) as a medicinal product and not as a food supplement?
(If any...)

Thanks!!

[LC_labrat]

I suggest referring to the ICH guidelines for impurities in drug products.

http://www.ich.org/fileadmin/Public_Web ... deline.pdf

http://www.ich.org/fileadmin/Public_Web ... Astep4.pdf

[an_k]

Thank you for answering.

I’m sorry but I wasn’t specific enough. I refer to vitamins which are fermentation products.
In such cases, q3b, q6a or the guideline of antibiotics do not apply.

Do you have any idea for such drug substances?

[prepcolumn]

As far as i know there is not a specific guideline for impurities of vitamins. I assume you are developing a generic product and you may set your limits according to the reference product results (impurity levels at the end of shelf life or stability results)

[an_k]

Yes, thank you!!