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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Measuring Nitrite and Nitrate, Metabolites in the Nitric Oxide Pathway, in Biological Materials using the Chemiluminescence Method
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Nitrite testing in excipients - Industry best practices.

Sebastian Hickert1, Kevin Näf2, Jinjian Zheng3

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Summary

Nitrosamine risk in pharmaceuticals is managed by detecting nitrites in excipients. This study evaluates analytical methods like IC, Griess, DAN, and cyclamate derivatization for accurate nitrite quantification, aiding risk assessment.

Keywords:
ExcipientsNDSRINitriteNitrite determinationNitrosamine

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Area of Science:

  • Pharmaceutical analysis
  • Analytical chemistry
  • Drug safety

Background:

  • Nitrites in pharmaceutical excipients can react with amines to form potentially carcinogenic N-nitrosamines.
  • Accurate detection and quantification of nitrites are crucial for N-nitrosamine risk assessment and mitigation in drug development.
  • An industry consortium and database were established to address challenges in nitrite analysis.

Purpose of the Study:

  • To review and demonstrate analytical techniques for quantifying nitrite in pharmaceutical excipients.
  • To share knowledge and best practices among industry partners.
  • To facilitate the selection of appropriate analytical methods for nitrite determination.

Main Methods:

  • Ion chromatography (IC) with conductivity or UV detection.
  • Griess derivatization followed by HPLC-UV or MS/MS detection, or as post-column derivatization (PCD) after IC.
  • 2,3-Diaminonaphthalene (DAN) derivatization with fluorescence (FL) and mass spectrometry (MS) detection.
  • Cyclamate derivatization with gas chromatography-flame ionization detection (GC-FID) or GC-MS detection.

Main Results:

  • The study details the principles, performance characteristics, and sample preparation for various analytical techniques.
  • Utilizing consortium data revealed a range of achievable limits of quantification (LOQs) for nitrite.
  • Advantages and disadvantages of each analytical technique were identified.

Conclusions:

  • A variety of validated analytical methods exist for nitrite quantification in excipients.
  • Understanding the performance and limitations of each technique is essential for effective N-nitrosamine risk management.
  • This work supports informed selection of analytical methods for pharmaceutical quality control.