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Placebo peak grows

Posted: Wed Aug 25, 2010 4:25 am
by Jenny
Hello everyone,

One of the placebo peaks grows during forced degradation of the degradant method validation.

Is it considered an "unknown degradant" or still just a "placebo"?

Please help.

Thanks.

Posted: Wed Aug 25, 2010 6:34 am
by Alex Buske
There is no reason why placebo substances shouldn't degrade. If it grows in pure placebo as much as in plaxcebo+API then it should be considered a placebo peak. in any other cases 'unknown degradand".

Posted: Wed Aug 25, 2010 1:19 pm
by Jenny
Thanks, Alex.

Yes, it grows in both.
I overlay Placebo chro. and Sample chro.; the peak is the same size.
Btw, I work with sample contains preservatives. Any extra clue?

If it's considered a placebo peak, it doesn't matter how big it grows? It means the product is not totally safe?