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Quantification and Identification of Visible and Subvisible Particulates from Elastomeric Components Contributing to the Total Particle Count of Pharmaceutical Products

Published online by Cambridge University Press:  04 August 2017

Evita McPherson ,
Christopher Bingham ,
Danequa Carter ,
William Toomey ,
Megan Scofield  and
Rebecca Pulvirenti
Evita McPherson
Affiliation:
Luitpold Pharmaceuticals, QC Particulate Laboratory, Shirley NY, United States.
Christopher Bingham
Affiliation:
Luitpold Pharmaceuticals, QC Particulate Laboratory, Shirley NY, United States.
Danequa Carter
Affiliation:
Luitpold Pharmaceuticals, QC Particulate Laboratory, Shirley NY, United States.
William Toomey
Affiliation:
Luitpold Pharmaceuticals, QC Particulate Laboratory, Shirley NY, United States.
Megan Scofield
Affiliation:
Luitpold Pharmaceuticals, QC Particulate Laboratory, Shirley NY, United States.
Rebecca Pulvirenti
Affiliation:
Luitpold Pharmaceuticals, QC Particulate Laboratory, Shirley NY, United States.

Abstract

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Type
Abstract
Information
Microscopy and Microanalysis , Volume 23 , Supplement S1: Proceedings of Microscopy & Microanalysis 2017 , July 2017 , pp. 1218 - 1219
Copyright
© Microscopy Society of America 2017 

References

[1] <788> Particulate Matter in Injections. In: The United States Pharmacopeia, 35th revision. Rockville, MD: The United States Pharmacopeial Convention, (2012).+Particulate+Matter+in+Injections.+In:+The+United+States+Pharmacopeia,+35th+revision.+Rockville,+MD:+The+United+States+Pharmacopeial+Convention,+(2012).>Google Scholar
[2] Internal Standard ISO 8871-3: Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use — Part 3: Determination of Released-Particle Count, First Edition, 2003.Google Scholar
[3] Scott Aldrich is thanked for his many useful discussions and contributions to this work.Google Scholar