Latest Innovations in Analytical Chemistry
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Latest Innovations in Analytical Chemistry

Stacey Smith, Pharma Tech Outlook | Sunday, March 15, 2020

Analyses have traditionally been used to quantify the active component and contaminants. Unexpected additions to formulations, such as elemental impurities caused by manufacturing containers, reactants, and other factors, may now be estimated due to innovation.

FREMONT, CA: Using a novel approach to analytical chemistry can help to increase efficiency and shorten important timeframes in delivering important medicines to patients. While Contract Development and Manufacturing Organizations (CDMOs) can help pharmaceutical businesses with their analytical needs for both small and large-scale projects, there is a chance to improve time to market by thinking outside the box. The section below includes innovation in analytical chemistry.

Innovative Analytical Chemistry Approaches

CDMOs are constantly looking for new ways to provide added value to their clients. The automation of analytical instrumentation is becoming easier as more systematic approaches are adopted. As a result, the amount of data produced is increasing while the amount of resources required to produce it is decreasing, which has significant benefits for businesses given the rising market demand.

Only a forward-thinking, innovative mindset, combined with close monitoring of developing technological breakthroughs, can lead to the development of high-quality products. It is becoming increasingly necessary to estimate not only the expected but also the unexpected. Analyses have traditionally been used to quantify the active component and contaminants. Unexpected additions to formulations, such as elemental impurities caused by manufacturing containers, reactants, and other factors, may now be estimated due to innovation.

Previously, elemental impurities were assessed using traditional methods such as heavy metals tests and arsenic limits. Raman spectroscopy, Nuclear Magnetic Resonance (NMR), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Optical Emission Spectroscopy (OES), and Ultra-Performance Liquid Chromatography (UPLC) are now being phased out in favor of more modern analytical techniques. Organizations can ensure product safety and efficacy during method development by using different detectors such as a refractive index detector, a fluorescence detector, an evaporative light scattering detector (ELSD), and Quadrupole Dalton (QDa) detectors. This helps to provide comprehensive information for regulatory authorities. Furthermore, orthogonal analytical techniques aid in a better knowledge of the product composition, both subjectively and quantitatively, in terms of Q1 (qualitatively) and Q2 (quantitatively) compliance. These strategies are assisting in reducing timescales and, as a result, allowing medicines to be put to market faster.

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