From The Corner Lab - Blog Posts


Posted by Jim Menoutis on Mon, Sep 28, 2015 @ 04:07 PM

On Wednesday, September 23, 2015, the U.S. Food and Drug Administration and IPEC-Americas published their finding on the levels of elemental impurities in select pharmaceutical excipients.

They present a survey of elemental impurity concentrations in a variety of excipients commonly used in pharmaceutical products as well as some drug substances. One hundred and ninety (190) pharmaceutical excipient samples and 15 drug substance samples were supplied by excipient manufacturers through IPEC-Americas. The samples included 31 different excipients that are commonly used in pharmaceutical manufacturing and eight different drug substances, and many were provided from multiple manufacturers and in several lots from the same manufacturer.

The paper describes the details of the analytical procedure used by the US FDA Division of Pharmaceutical Analysis. The analysis of these materials utilized a robust method of closed vessel digestion which is suitable for a wide variety of excipients and drug substances with appropriate modification, and the digested samples were analyzed by inductively coupled plasma mass spectrometry (ICP-MS). It includes the analytical results and a description of the capabilities of the procedures.

One of the key finding for most of the 190 excipient samples tested, was when the observed concentrations of elemental impurities from these excipients were compared with relevant limits for potentially harmful elemental concentrations, the excipient’s elemental impurity levels were found to be well below concentrations of concern. 

The paper also provides a brief discussion of some analytical challenges, and some potential solutions to those challenges. To download a copy of the published FDA study click here.



Topics: USP <232> USP <2332>, Elemental Impurities, Q3D