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Vitamins Guidance
Posted: Wed Feb 13, 2013 11:53 am
by 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!!
Re: Vitamins Guidance
Posted: Wed Feb 13, 2013 8:14 pm
by LC_labrat
Re: Vitamins Guidance
Posted: Thu Feb 14, 2013 12:47 pm
by 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?
Re: Vitamins Guidance
Posted: Fri Feb 15, 2013 7:05 am
by 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)
Re: Vitamins Guidance
Posted: Fri Feb 15, 2013 9:19 am
by an_k
Yes, thank you!!