摘要：The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)reviewed the article "Identification of Phthalates in Medications and Dietary Supplement Formulations in the United States and Canada" by Kelley et al. (2012). This article contains inaccuracies and mis-leading statements, and the terminology used by Kelly et al. was incorrect. Speaking for IPEC-Americas, I would like to rectify any confusion caused by their colloquial use of the term "phthalate." The term "phthalate" has been defined by the U.S. Environmental Protection Agency (EPA) and other regulatory agencies to identify diesters of ortho phthalic acid, also called simply phthalic acid, an aromatic dicarboxylic acid in which the two carboxylic acid groups are located on adjacent carbons (positions 1 and 2) in the benzene ring. Both di-n-butyl phthalate (DBP) and di-(2-ethyl-hexyl) phthalate (DEHP) are examples of such phthalates; these phthalates are chemi-cally and toxicologically distinct from diesters of iso phthalic or tere phthalic acids, which are not considered to be true "phthalates," as defined by the U.S. EPA (2012). Kelley et al. (2012) failed to acknowledge these impor-tant distinctions and incorrectly grouped iso phthalic and tere phthalic acid derivatives with the ortho-phthalates. This colloquial use of "phthalates" has created unsubstantiated and erroneous safety concerns. The specific toxicological concern with DEHP and DBP arises from their metabolic conversion to their corresponding monoesters
