CEM Microwave Instruments are Ideal for Sample Preparation for Metal Analysis of Pharmaceuticals

Heavy metals are highly toxic and so it is important to ensure that people are protected from anything they ingest which could potentially be contaminated, including pharmaceuticals and drugs.

In America the United States Pharmacopeia (USP) chapter 231, has, since 1905, set out the methods for determining the amount of various heavy metals in pharmaceutical products and raw materials. This approach was updated in 2014 to address matters such as the loss of dangerous volatile metals during sample preparation, and the need for large amounts of sample.

This update has prompted CEM, innovators in the laboratory application of microwave technology, to evaluate how well their instruments might assist manufacturers to conform to the new USP Chapters 232 and 233.

CEM used their Discover® SP-D and the MARS 6™ instruments, both of which employ completely sealed sample vessels, as opposed to caps and three different pharmaceutical products were prepared for subsequent metal analysis.

Of the four methods preparation methods outlined in USP Chapter 232, Neat, Direct Aqueous Solution, Direct Organic Solution, and Indirect Solution, it is Indirect Solution that is required for most pharmaceutical raw materials, because it is otherwise difficult to get the sample totally dissolved. With microwave digestion, the direct transfer of heat to the sample matrix is particularly advantageous for Indirect Solution.

CEM’s results indicate that both their instruments are well suited for fast, simple, and safe sample preparation of pharmaceutical products and raw materials for metals analysis.

The use of sealed vessels, as opposed to caps, eliminates cross contamination and it is possible to recover both volatile and non-volatile metals. Microwave digestion saves time and is less labour-intensive as the instruments can be left unattended.

The choice of instrument would simply depend on the sample throughput of the laboratory as both the Discover® SP-D and the MARS 6™ include pre-programmed methods and intuitive software; expert applications assistance as well as CEM’s guide to implementing the new USP chapters.

Date added: 2016-04-01 15:19:22