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Re: drugn product degradent
A different synthetic route can certainly lead to different degradation. I had an example where one process involved catalysis and the other did not. The two API's both based specification but one degraded quite rapidly whereas the other was stable. Malcolm Ross Generapharm -- Dr. Malcolm Ross Generapharm-Training and Consultancy Rümelinbachweg 16 Basel 4054 Switzerland The GMP Discussion Group is sponsored by gmp review - see http://www.pharmweb.net/gmp.html |
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