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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
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Eliminating pharmaceutical impurities: Recent advances in detection techniques.

David Q Liu1, Mingjiang Sun, Lianming Wu

  • 1GlaxoSmithKline plc, Analytical Sciences, King of Prussia, PA 19406, USA. david.q.liu@gsk.com

Current Opinion in Drug Discovery & Development
|November 10, 2010
PubMed
Summary
This summary is machine-generated.

Process chemistry aims to eliminate organic impurities for drug purity. Advanced techniques like LC-MS and MS-based strategies improve detection of trace genotoxic impurities (GTIs).

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Area of Science:

  • Analytical Chemistry
  • Process Chemistry
  • Pharmaceutical Science

Background:

  • Producing highly pure drug substances requires eliminating organic impurities.
  • Genotoxic impurities (GTIs) demand stringent control at parts-per-million levels.
  • Conventional detection methods like UV are often insufficient for trace GTI detection.

Purpose of the Study:

  • To review recent advancements in detecting impurities at trace levels.
  • To focus on qualitative and quantitative detection of genotoxic impurities (GTIs).
  • To highlight the role of advanced mass spectrometry (MS)-based detection strategies.

Main Methods:

  • Utilizing hyphenated techniques such as liquid chromatography-mass spectrometry (LC-MS) for structural identification.
  • Employing advanced MS-based detection strategies for sensitive quantitation.
  • Integrating chemical approaches with MS detection for enhanced impurity analysis.

Main Results:

  • LC-MS enables rapid structural identification and understanding of impurity formation mechanisms.
  • Advanced MS-based detection offers selective and sensitive quantitation of trace impurities, including GTIs.
  • Significant progress has been made in controlling and eliminating process-related impurities.

Conclusions:

  • Advanced MS-based detection is crucial for overcoming limitations of conventional methods in impurity analysis.
  • Improved qualitative and quantitative detection of trace impurities, especially GTIs, is vital for drug safety.
  • Continued development in analytical techniques supports the goal of producing highly pure drug substances.