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Research ArticleResearch

There Is Still Room for Improvement: Presentation of a Neutral Borosilicate Glass with Improved Chemical Stability for Parenteral Packaging

Bettine Boltres, Stephan Tratzky, Christof Kass, Rainer Eichholz and Peter Naß
PDA Journal of Pharmaceutical Science and Technology July 2016, 70 (4) 346-352; DOI: https://doi.org/10.5731/pdajpst.2015.005934
Bettine Boltres
Schott AG Mitterteich, Mitterteich, Germany
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  • For correspondence: bettine.boltres@schott.com
Stephan Tratzky
Schott AG Mitterteich, Mitterteich, Germany
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Christof Kass
Schott AG Mitterteich, Mitterteich, Germany
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Rainer Eichholz
Schott AG Mitterteich, Mitterteich, Germany
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Peter Naß
Schott AG Mitterteich, Mitterteich, Germany
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References

  1. 1.↵
    ASTME 438-92. Standard Specification for Glasses in Laboratory Apparatus; American Society for Testing and Materials: Conshohocken, PA, 2011.
    Google Scholar
  2. 2.↵
    ISO 12775. Guidelines on Types of Glass of Normal Bulk-Production Composition and Their Test Methods. International Organization for Standardization, 1997.
    Google Scholar
  3. 3.↵
    Ph. Eur. 8.4, Chapter 3.2. Containers, European Pharmacopoeia; Council of Europe: Strasbourg, France, 2014.
    Google Scholar
  4. 4.↵
    USP 38, NF 33, Chapter <660> Containers—Glass. United States Pharmacopeia; U.S. Pharmacopeial Convention: Rockville, MD, 2015.
    Google Scholar
  5. 5.↵
    1. Tratzky S.,
    2. Kass C.,
    3. Eichholz R.,
    4. Nass P.
    Borosilicate Glass Having Improved Hydrolytic Resistance for Preferred Use in the Pharmaceutical Sector. US Patent US 20140323287 A1, 2014.
    Google Scholar
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PDA Journal of Pharmaceutical Science and Technology: 70 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 4
July/August 2016
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There Is Still Room for Improvement: Presentation of a Neutral Borosilicate Glass with Improved Chemical Stability for Parenteral Packaging
Bettine Boltres, Stephan Tratzky, Christof Kass, Rainer Eichholz, Peter Naß
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 346-352; DOI: 10.5731/pdajpst.2015.005934
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Keywords

  • Glass
  • Primary packaging
  • Borosilicate glass
  • Chemical stability
  • Extractables and leachables
  • Accelerated ageing study
  • Phosphate buffer
  • Carbonate buffer

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There Is Still Room for Improvement: Presentation of a Neutral Borosilicate Glass with Improved Chemical Stability for Parenteral Packaging
Bettine Boltres, Stephan Tratzky, Christof Kass, Rainer Eichholz, Peter Naß
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 346-352; DOI: 10.5731/pdajpst.2015.005934

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