Elemental Impurity analysis in Pharmaceutical Products-Plasma Spectroscopy in Pharma – A Primer

Elemental Impurity analysis in Pharmaceutical Products-Plasma Spectroscopy in Pharma – A Primer

Overview

  • Post By : Kumar Jeetendra
  • Source: Analytik Jena
  • Date: 08 April, 2019

It’s the duty and responsibility of the manufacturer to ensure that a pharmaceutical product is having the right dose of the lifesaving drug and free from any form of unwanted and harmful contaminants. Health agenesis like FDA regulate the pharmaceutical market by issuing guide linesfor identity, strength, quality and purity of drug products and their ingredients through USP.

Elemental impurities in Pharmaceutical products can be rooted from A. source of the ingredients used in preparation (e.g. Herbs), B. process of drug compound synthesis (e.g. Catalysts) or C. manufacturing process (e.g. molding, packaging). Although there have been no known health related incidents from elemental contamination in pharma products, but it has been scientifically established that elementals like Arsenic, Mercury, Cadmium, Lead are of potential toxic nature.

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