News
04-August 2010 - Fighting the counterfeit drug war –
LGC detects fake packaging using mass spectrometry
LGC announces new advance in the battle to detect
counterfeit drug packaging
LGC, the UK’s designated National Measurement Institute for chemical and
bioanalytical measurement, is using high accuracy mass spectrometry
(MS) for the first time to measure variations of calcium (Ca) and
lead (Pb) isotope ratios in order to identify counterfeit
pharmaceutical packaging. By applying this technique to look at Ca
and Pb isotope ratios in the cardboard packaging and printing ink
used in drug cartons and containers, scientists can now potentially
distinguish the source of origin of packaging materials, thus
providing valuable evidence against drug counterfeiters for
subsequent prosecutions.
Detecting counterfeit drugs and packaging has traditionally
relied on a combination of visual examination and chemical analysis
of the goods and packaging. However, as counterfeiting techniques
are becoming increasingly sophisticated, more sensitive detection
methods are required. Many counterfeit pharmaceuticals now contain
the same active pharmaceutical ingredient as the genuine product,
so their elemental composition is often very similar, if not
identical to that of the real drug. In addition, both genuine
manufacturers and counterfeiters often combine a number of elements
of packaging materials sourced from different suppliers, thus
making it difficult to identify counterfeits that have been seized
in different locations.
To develop methods to help identify counterfeit pharmaceutical
packaging, LGC scientists have worked on a research project in
collaboration with GlaxoSmithKline and funded by the UK National Measurement System.
All naturally occurring elements consist of one or more stable
isotopes and the isotopic profile of elements can reveal subtle
variations depending on the source of origin. Advances in mass
spectrometry have made possible the detection of these
variations.
Described in a recently published primary paper*, LGC
scientists used a laser ablation system coupled to a multicollector
inductively coupled plasma mass spectrometer (LA-MC-ICP-MS) to
measure and compare Ca and Pb isotope ratios of nine pharmaceutical
packaging samples.
As Ca is used in the cardboard/papermaking process and Pb is a
major component of ink, both elements are expected to be present in
packaging (cardboard/ink) at relatively high concentrations. The
results of the LGC study showed that, of the nine samples analysed,
the five authentic samples displayed different Ca isotope ratios to
those of the counterfeit samples. When analysed and plotted, the Ca
isotope ratios of two counterfeit samples known to come from the
same country clustered together. Two further counterfeit samples,
from different countries, also had similar Ca isotope ratios to the
first two counterfeit samples analysed. Isotope ratio analysis of
Pb showed similar clustering of results.
LGC’s Dr Ruth Hearn, Team Leader in Chemical Measurement and Calibration said:
“Working in collaboration with GlaxoSmithKline was vital to the
success of this project because it enabled LGC to gain first-hand
insight to the problems faced by pharmaceutical companies in
tackling drug counterfeiting. This successful collaboration has
enabled LGC to demonstrate the technique’s potential to be used by
the global pharmaceutical industry as a tool for the identification
of counterfeit drugs.”
LGC is also using the same technique to provide high accuracy
sulfur isotope ratio measurements to identify counterfeit
pharmaceutical drugs.
* Application of laser ablation multicollector inductively
coupled plasma mass spectrometry for the measurement of calcium and
lead isotope ratios in packaging for discriminatory purposes,
Rebeca Santamaria-Fernandez and Jean-Claude Wolff
Rapid Commun. Mass Spectrom. 2010; 24: 1993–1999
- Ends -
Notes to editors