New ICH & USP Regulations: Is Your Analyzer Ready?

New ICH & USP Regulations: Is Your Analyzer Ready?

As a pharmaceutical processor, you’ve got to know if your analyzer can help comply with new European and U.S. regulations. A good ICP-MS machine might work — but mass spec is expensive. Fortunately, the latest (and more affordable) ICP-OES spectrometers can also do the job. They handle high matrix loads, enabling efficient analysis with simple sample prep and no added dilution.

Here’s how to test an advanced ICP-OES analyzer against the latest ICH Q3D and USP <232>, <233>, <2232> standards for determining heavy metal impurities in low-dose pharmaceuticals.

Check Impurity Limits


Determine Target Limits


Find Analyzer’s Limits of Detection


Test Analyzer’s Accuracy


Test Analyzer’s Repeatability

The advanced, late-model ICP-OES analyzer used here easily met every one of the new ICH and USP requirements. Is your analyzer ready?