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Research ArticleTechnology/Application

Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations

Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair and Deirdre Murphy Piedmonte
PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 96-107; DOI: https://doi.org/10.5731/pdajpst.2015.01007
Renuka Thirumangalathu
‡Drug Product Development, Process and Product Development, Amgen Inc., Thousand Oaks, CA; and
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  • For correspondence: renukat@amgen.com
Kwun Ngok Wong
‡Drug Product Development, Process and Product Development, Amgen Inc., Thousand Oaks, CA; and
§Current address: University of Southern California, Los Angeles, CA 90089
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James Coultas
‡Drug Product Development, Process and Product Development, Amgen Inc., Thousand Oaks, CA; and
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Alison Hair
‡Drug Product Development, Process and Product Development, Amgen Inc., Thousand Oaks, CA; and
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Deirdre Murphy Piedmonte
‡Drug Product Development, Process and Product Development, Amgen Inc., Thousand Oaks, CA; and
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Abstract

The primary container for parenterals is usually composed of glass. Given the recent industry-wide spike in glass-related problems, assays capable of detecting glass degradation before glass-related particles are visible in solution have practical significance. A rapid, high-throughput ion chromatography method coupled with molybdate reaction is described here for detection and quantitation of silicic acid (soluble form of silica) in complex samples. The method involves ion exchange separation of the silicate anion at high pH followed by a post-column derivatization step with sodium molybdate reagent. The resulting molybdo-silicate complex is detected with high sensitivity in the visible wavelength range at 410 nm and correlates to the level of soluble silica in solution. This assay is high-throughput and amenable for implementation during the early phase of product development. The assay provides a direct measurement to assess potential incompatibility between the formulation and its glass container. The Si levels measured by this method showed a direct correlation to the vial surface morphology changes as monitored by differential interference contrast microscopy.

LAY ABSTRACT: Recently, the pharmaceutical industry has been faced with glass quality challenges that have resulted in many products being recalled from the market. Monitoring levels of soluble silica in solution is critical because silica is the primary component of glass containers used in the pharmaceutical industry. Given this recent industry-wide increase in glass-related problems, assays capable of detecting glass degradation before glass-related particles are visible in solution have practical significance. A rapid assay to detect the soluble form of silica is presented here. The method presented will enable earlier detection of a formulation and container incompatibility instead of waiting until glass-related particles are visible in solution.

  • Silicic acid
  • Soluble silica
  • Glass delamination
  • Glass degradation
  • Ion chromatography
  • Formulation container incompatibility
  • Molybdate
  • Silico-molybdate complex
  • Glass lamellae
  • Glass dissolution
  • © PDA, Inc. 2015
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PDA Journal of Pharmaceutical Science and Technology: 69 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 1
January/February 2015
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Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair, Deirdre Murphy Piedmonte
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 96-107; DOI: 10.5731/pdajpst.2015.01007

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Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair, Deirdre Murphy Piedmonte
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 96-107; DOI: 10.5731/pdajpst.2015.01007
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Keywords

  • Silicic acid
  • Soluble silica
  • Glass delamination
  • Glass degradation
  • Ion chromatography
  • Formulation container incompatibility
  • Molybdate
  • Silico-molybdate complex
  • Glass lamellae
  • glass dissolution

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