Increasing demand from applied markets and requirement to comply with the revised regulatory norms are creating awareness on elemental analysis in India. M Jagadish Naidu, Business Manager for inorganic product line, PerkinElmer India, throws more light on the same
India elemental analysis market is segmented on the basis of types, technologies and applications. New international GMP and GDP certification, proposed revision from regulatory bodies like USP, ICH, EN etc and growing food safety / Environment safety concerns are major factors driving the demand for elemental analysis in India. Notable advancements took place across techniques such as Inductively Coupled Plasma Spectrometry (ICP), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), and Atomic Absorption Spectrometry (AAS) to meet the needs of rapidly evolving industry challenges across applications. Increasing demand from applied markets, and requirement to comply with the revised regulatory norms are creating awareness on elemental analysis in India.
ICP-MS broadly finds applications in the following markets:
- Life sciences – Pharma Food and beverage testing
- Environment testing
- Geology
- Others (Chemical, oil and gas, and cosmetics industries)
Major growth drivers for ICPMS in India
- Pharmaceuticals: The Indian pharmaceutical market is the third largest in terms of volume and 13th largest in terms of value#. Branded generics dominate the pharma market, constituting nearly 70 to 80 per cent of the market. Indian generics accounting for 20 per cent of global exports in terms of volume. The Indian pharma market increased at a CAGR of 17.46 per cent in 2015 from $6 billion in 2005 and is expected to expand at a CAGR of 15.92 per cent to $ 55 billion by 2020. India is likely to be among the top three pharma markets by incremental growth and sixth largest market globally in absolute size.
With the advent of recent changes implemented by the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP) and other international regulatory bodies for constraining inorganic impurities in pharma and drug products, there has been a demand for this technique across pharma drug product manufacturing cycle.
The general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. These impurities may occur naturally, be added intentionally, or be introduced inadvertently (e.g., by interactions with processing equipment and the container closure system).
The USP Convention has announced the establishment of an implementation date of January 1, 2018 for General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in dietary supplements in USP’s compendia of public standards. This will provide a huge opportunity for the ICPMS business growth in India.
- Food: India food sector has emerged as a high-growth and high-profit sector due to its immense potential for value addition, particularly within the food processing industry. The Indian food processing industry accounts for 32 per cent of the country’s total food market, one of the largest industries in India and is expected to grow at a CAGR of 11 per cent by 2018.
One of the drivers behind India’s growth in food market is its government support towards irrigation, power, fertilizer, which boosts production for many exported crops. Indian government is taking all necessary actions to harmonise India regulations with standards of international agencies to drive exports. Key regulatory bodies that govern the food safety standards in India are Food Safety and Standard Authority of India, Ministry of Food processing industries & Agriculture and processed foods export development authority.
Elemental analysis in food products has become mandatory due to environmental pollution caused by human agencies leading to adverse health concerns. Hence, food quality monitoring has become a basic necessity for the government and manufacturers. ICPMS technology exhibits the versatility to screen varied food products for trace elemental contaminants and understand the source of contamination.
- Academia and research: The research ecosystem in India presents a significant opportunity due to its intellectual capital available in the country. Government of India has taken several steps to promote the R&D sector in India and announced plans to establish National Institution to Transforming India (NITI) to increase involvement of entrepreneurs, researchers to foster scientific innovations
Research in India used to be carried out by few of the major institutes / universities. Government of India is encouraging government private collaborations to enhance research across disciplines. Currently only 25 per cent of the universities undertake research activities and this is going to double by 2020. - Others: While pharma, food and academia will continue to be the major markets for ICPMS in India, we will also continue to have opportunities across chemical and environment, HPI etc.
Introduction
Inductively coupled plasma mass spectrometry (ICP-MS) is a very sensitive elemental analysis technique capable of analysing wide variety of sample types. This technique is reviewed as an alternative nuclear analytical technique for the determination of radioisotopes, the latest development and advancements in utilisation of collision and reaction cells offers unrivaled flexibility for solving difficult applications. In this technique, the ionised sample created by the plasma is drawn into the intake for a mass spectrometer. This forms the basis of ICP-MS technology, which generally requires liquid or dissolved samples. For solids, glow discharge or laser ablation can be used to produce ions, performance by eliminating mass
interferences.
Trends : Recently ICP-MS has become a favoured technique for the fast and accurate determination of trace and ultra-trace elements in many matrices due to its low sample consumption, high sensitivity, excellent precision, and potential for multi-element analysis.
However, isobaric and polyatomic interferences can significantly affect the accuracy of ICP-MS analyses, especially for radioisotopes. Suppression of these interferences has been the subject of many studies. Although there are ways to minimise these interferences — including correction equations, cool plasma technology, and matrix separation — they cannot be completely eliminated.
Interferences
A new approach called collision/reaction cell technology has recently been developed that virtually stops the formation of many of these harmful species before they enter the mass analyser. Complex secondary reactions and collisions take place, which generate many undesirable interfering species. If these species were not eliminated or rejected, they could potentially lead to additional spectral interferences.
Basically two approaches are used to reject the products of these unwanted interactions:
- Discrimination by kinetic energy
- Discrimination by mass.
Collision/reaction cells have given a new lease on life to quadrupole mass analysers used in ICP-MS. They have enhanced its performance and flexibility and most definitely opened up the technique to more-demanding applications that were previously beyond its capabilities.
Advanced techniques
The use of inductively coupled plasma mass spectrometry (ICP-MS) coupled with separation techniques for the purpose of elemental speciation has gained a lot of attention across applications.
Speciation is defined as the ability to measure multiple forms of the same element, the various forms can be differences in oxidation
state or other atoms associated with the element of interest. Elemental speciation analysis has only developed during the last two decades with the evolution of instrumental detection powers coupled with the knowledge that speciation leads to a better understanding of elements in our environment.
Reference
[1] Strategic Directions International, Inc. Market Forecast (2012-2016).
[2] Markets and Markets –(June-2015) .
[3] Center for Single Nanoparticle, Single Cell, and Single Molecule Monitoring (CS3M), Missouri
[4] Spectroscopy online
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