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Declaration of the components of a substance
Hi,
I have an active ingredient which has been lyophilized by using a buffer. My concern is that I am not sure if I must declare the buffer or not. According to the EU regulation I think that maybe it could be considered as a necessary ingredient to keep the stability of the active and hence be considered an only substance and only declaring the INCI name of the active. I did some research but It is still not clear to me. Any advice or where to find this information? Thank you very much for your help
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