Article: Trace Element Analysis Of Heavy Metals In Pharmaceutical Materials

The pharmaceutical industry is heavily regulated beyond all other industries. This is for a good reason because many of the materials produced are potentially dangerous and can be severely toxic if not manufactured with proper care. Regulation has led to the mandatory examination of all substances from starting materials to finished products. Generally this includes the proof of product stability, drug-release profiles, Active- Pharmaceutical-Ingredient (API) form, API quantification, and product safety including sterility (for non-biological materials) and foreign materials including heavy-metals.

One of the most common product safety-related analytical tests (often referred to as a Limit Test) is the quantification of heavy metals or inorganics in all materials within a pharmaceutical product. This normally includes the toxic heavy metals such as As, Hg and Pb. Most of the elements identified for heavy metal Limit Testing have been well documented as significant health risks with numerous effects from organ failure to blindness and even death.

It is also common practice to measure catalysts, such as Pd and Pt, which are also well classified toxic elements. Throughout the manufacturing processes there are many potential sources of contamination. Therefore, in addition to measuring the starting materials it is essential to measure all finished products and in some cases intermediates, to demonstrate the compliancy with the various regulations.

The MiniPal 4 Pharma is an EDXRF benchtop instrument that is designed for the analysis of a wide variety elements from Na to U. To demonstrate the performance of the MiniPal 4 Pharma, seven heavy metals representing contaminants, stainless steel residuals and catalysts that are commonly analyzed were tested in pharmaceutical materials. This rapid analysis was conducted with minimal sample preparation.