A new era in pharma business

Amit Chopra, MD & VP/GM, Thermo Fisher Scientific, India and Middle East, explains how technology can help companies comply with regulations and meet customer expectations

Introduction and increased investments in R&D for developing new and technologically advanced products, implementation of regulations that mandate elemental analysis of pharma and healthcare products, and growing awareness amongst manufacturers as well as consumers due to conferences, meetings, and congresses, have influenced the pharma analysis market. As per Grand View Research report, the global elemental analysis market size is valued at $ 1.20 billion in 2016 and is projected to grow at a CAGR of 6.2 per cent.

Elemental analysers are used for organic, inorganic, qualitative and quantitative estimation of heavy metals and detecting traces of catalysts in a sample. In pharma samples, inorganic elements are analysed in range from heavy metals
to traces of catalysts. In 2016, analysis for inorganic elements held the largest market share which can be attributed to guidelines that provide allowable limits of heavy metals and trace metals in pharmacopoeias of various countries. Further, technologies for elemental analysis are segmented into Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), combustion analysis and other electroanalytical and chemical methods.

ICP-MS is an analytical technique used for elemental determinations. It was commercially introduced in 1983, and has gained general acceptance in many types of laboratories. Geochemical analysis labs were early adopters of ICP-MS technology because of its superior detection capabilities, particularly for the rare-earth elements (REEs). An ICP-MS combines a high-temperature ICP source with a mass spectrometer to convert the atoms of the elements in the sample to ions. These ions are then separated and detected by the mass spectrometer. Until recently, the numbers of AAS (Atomic Absorption Spectroscopy), ICP-OES and ICP-MS installations in pharma companies were limited and restricted to only major companies. An ICP-MS has many advantages over other elemental analysis techniques such as atomic absorption and optical emission spectrometry, including ICP Atomic Emission Spectroscopy (ICP-AES), including:

Detection limits for most elements equal to or better than those obtained by Graphite Furnace Atomic Absorption Spectroscopy (GFAAS)

• Higher throughput than GFAAS
• Ability to handle both simple and complex matrices with a minimum of matrix interferences due to the high-temperature of the ICP source
• Superior detection capability to ICP-OES with the same sample throughput
• Ability to obtain isotopic information.

Increase in research for the development of technologically advanced elemental analysers, upcoming regulations that mandate elemental analysis of finished medical products, USP guidelines and limits for elements in pharma compounds have led to an upsurge in applications of elemental analysis in healthcare and seize largest share in the pharma business.

While having the right technology is a critical aspect, customers also need to focus on other things like usage of high purity trace acids, NIST certified single/ multi element standards, high purity low ion content water, certified plastic ware that guarantee leach proof material of construction for use in sample preparation and storage play a crucial role in legislative compliance efforts.

The USP General Chapters which was initially planned for implementation in 2013 was deferred first in 2014 and subsequently to 2015. As pharma and control testing labs gear up to comply to the new norms that will come into effect in January 2018, there is a heavy dependency on the range of ICP-OES and ICP-MS instrumentation products and services that become crucial for pharma scientists, enabling users to meet the future legislative requirements while delivering accurate and
repeatable results. The proposed USP chapters mark a new era for the analysis of trace elemental impurities in pharma products and the industry must get equipped for the change.