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The pharmaceutical industry is one of the most regulated industries worldwide, since the drug products have to be safe and effective. The levels of impurities and degradation products in active… Click to show full abstract
The pharmaceutical industry is one of the most regulated industries worldwide, since the drug products have to be safe and effective. The levels of impurities and degradation products in active pharmaceutical ingredients (APIs) have to be strictly controlled and meet the specifications required by international authorities. Chromatography has been the technique of choice for many years to assess the chemical purity of drug substances and products and is widely used in the pharmaceutical industry, from research and development to quality control (QC) laboratories.
Journal Title: Analytical chemistry
Year Published: 2019
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