What's the amount of phenol residue limit in API?

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Saleh Rakhshani

In parental formulations, allowed phenol concentration is 0.5% as a preservative.

David E. Bautista-Erazo

Phenol is very toxic, I don't know the exact % but that chemical should be avoided.

Jay Gopal Meher

Dear Meng

Although phenol is toxic but it is allowed to certain concentation in formulations (along with API). It all depends on the route of intended drug administration. You can follow the FDA for your query.

http://www.accessdata.fda.gov/scripts/cder/iig/getiigWEB.cfm

Best