Elemental Impurities / ICP-MS

Overview

Elemental impurity testing measures trace chemical elements — such as certain metals — that may be present at low levels. ICP-MS is one analytical technique capable of measuring many elements at low concentrations.

What is being measured

Elemental impurity testing looks for specific chemical elements that may be present as trace contaminants rather than as part of the intended substance. These can enter a material from starting materials, processing, or equipment. The test characterises how much of a given element is present, not what the intended molecule is.

What ICP-MS does

ICP-MS (inductively coupled plasma mass spectrometry) uses a very high-temperature plasma to break a sample down to individual atoms and ionise them, then a mass spectrometer sorts those ions by their mass-to-charge ratio and counts them. This lets the technique measure many elements simultaneously and at low concentrations. It is one recognised approach among others for elemental analysis.

What an elemental result can and cannot tell you

An elemental result describes the measured amount of the elements the method targets, within its scope. It characterises trace-element content only. It does not describe identity, purity, or quantity of the intended substance, nor microbiological or endotoxin status — those are separate measurements answering separate questions.

What this test can and cannot establish

Key terminology

Elemental impurity

A chemical element present as a trace contaminant.

ICP-MS

Inductively coupled plasma mass spectrometry — an analytical technique for measuring elements at low levels.

Mass-to-charge ratio

The property a mass spectrometer uses to sort ions.