Guidance warns against using 2 phthalates as drug excipient

03/27/2012 | InPharm.com

The FDA said in draft guidance that drugmakers should avoid using dibutyl phthalate and di(2-ethylhexyl) phthalate as an excipient in pharmaceutical and biologic products because they could be toxic to humans. The agency's Inactive Ingredients Database lists possible alternatives to the two phthalates.

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