11. Investigation of Degradation Products and Extractables in Developing Topical OTC (Over the Counter) and NCE (New Chemical Entity) Consumer Healthcare Medication Products

  1. Birendra N. Pramanik2,
  2. Mike S. Lee3 and
  3. Guodong Chen4
  1. Fa Zhang

Published Online: 12 JUL 2011

DOI: 10.1002/9780470921371.ch11

Characterization of Impurities and Degradants Using Mass Spectrometry

Characterization of Impurities and Degradants Using Mass Spectrometry

How to Cite

Zhang, F. (2011) Investigation of Degradation Products and Extractables in Developing Topical OTC (Over the Counter) and NCE (New Chemical Entity) Consumer Healthcare Medication Products, in Characterization of Impurities and Degradants Using Mass Spectrometry (eds B. N. Pramanik, M. S. Lee and G. Chen), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470921371.ch11

Editor Information

  1. 2

    Merck and Co., Kenilworth, NJ, USA

  2. 3

    Milestone Development Services, Newtown, PA, USA

  3. 4

    Bristol-Myers Squibb Company, Princeton, NJ, USA

Author Information

  1. Analytical Development, Johnson & Johnson Consumer and Personal Products Worldwide, Skillman, NJ 08558, USA

Publication History

  1. Published Online: 12 JUL 2011
  2. Published Print: 16 MAY 2011

Book Series:

  1. Wiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications, and Methods

Book Series Editors:

  1. Mike S. Lee

Series Editor Information

  1. Milestone Development Services, Newtown, PA, USA

ISBN Information

Print ISBN: 9780470386187

Online ISBN: 9780470921371

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Keywords:

  • degradation product and extractable investigation, topical OTC (Over the Counter) - and NCE (New Chemical Entity) consumer healthcare medication products;
  • extractables or leachables from packages, rubber closures - detrimental, leachables in drug product, levels being low, if present;
  • reductive degradation of a 1,2,4-thiadiazolium - derivative reductive degradation, a neglected area

Summary

This chapter contains sections titled:

  • Introduction

  • Oxidatively Induced Coupling of Miconazole Nitrate with Butylated Hydroxytoluene in a Topical Ointment

  • Extractables from Rubber Closures of a Prefilled Semisolid Drug Applicator

  • New Degradation Products and Pathways of Vitamin D and Its Analogs

  • Reductive Degradation of a 1,2,4-Thiadiazolium Derivative

  • Conclusions

  • References