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Review ArticleReview

Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients: Are They Critical Quality Attributes?

Anthony M. Cundell
PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 386-393; DOI: https://doi.org/10.5731/pdajpst.2014.00997
Anthony M. Cundell
Consulting Microbiologist, Scarsdale, NY
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  • For correspondence: tonycundell@gmail.com
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Article Information

vol. 68 no. 5 386-393
DOI 
https://doi.org/10.5731/pdajpst.2014.00997
PubMed 
25336414

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 21, 2014.

Copyright & Usage 
© PDA, Inc. 2014

Author Information

  1. Anthony M. Cundell*
  1. Consulting Microbiologist, Scarsdale, NY
  1. ↵*Corresponding Address: 105 Lee Road, Scarsdale, NY 10583, USA. e-mail: tonycundell{at}gmail.com
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PDA Journal of Pharmaceutical Science and Technology: 68 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 5
September/October 2014
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Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients: Are They Critical Quality Attributes?
Anthony M. Cundell
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 386-393; DOI: 10.5731/pdajpst.2014.00997

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Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients: Are They Critical Quality Attributes?
Anthony M. Cundell
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 386-393; DOI: 10.5731/pdajpst.2014.00997
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  • Article
    • Abstract
    • Introduction
    • Occupational Exposure to Bacterial Endotoxins
    • Bacterial Endotoxin Assays
    • Bacterial Endotoxins Specifications for Excipients and Drug Product
    • 1. Review of the Endotoxins Requirements for Other Inhalation Products and Their Excipients
    • 2. Comparison of the Normal Endotoxins Exposure to the Dosage Level Obtained When Using an Inhaler
    • 3. Determining the No-Effect Level and Using It to Set an Endotoxin Requirement
    • Bacterial Endotoxin Specification for DPIs
    • Environmental Endotoxins
    • Recommendations
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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More in this TOC Section

  • The Role of Microbiologists in Drug Product Development
  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
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