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Microscopic Analysis of Particulates in Pharmaceutical Products: A Case Study

Published online by Cambridge University Press:  22 July 2022

Youlong Ma ,
Charudharshini Srinivasan  and
Muhammad Ashraf
Youlong Ma
Affiliation:
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, MD, USA
Charudharshini Srinivasan*
Affiliation:
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, MD, USA
Muhammad Ashraf
Affiliation:
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, MD, USA
*
*Corresponding author: Charudharshini.Srinivasan@fda.hhs.gov

Abstract

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Type
On Demand - Imaging, Microscopy, and Micro/Nano-Analysis of Pharmaceutical, Biopharmaceutical, and Medical Health Products - Research, Development, Analysis, Regulation, and Commercialization
Information
Microscopy and Microanalysis , Volume 28 , Supplement S1 , August 2022 , pp. 1444 - 1446
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Copyright
Copyright © Microscopy Society of America 2022

References

Schumacher, Ef, et al. Microscopy and Microanalysis 21 (2015), p. 395-396.CrossRefGoogle Scholar
Srinivasan, C., et al. International Journal of Pharmaceutics (2019), p. 118510.Google Scholar
USP <788> Particulate Matter in Injections. Rockville, MD: US Pharmacopeia, (2013).+Particulate+Matter+in+Injections.+Rockville,+MD:+US+Pharmacopeia,+(2013).>Google Scholar
USP <1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions. Rockville, MD: US Pharmacopeia, (2018)+Methods+for+the+Determination+of+Particulate+Matter+in+Injections+and+Ophthalmic+Solutions.+Rockville,+MD:+US+Pharmacopeia,+(2018)>Google Scholar
Ma, Y., et al. International Journal of Pharmaceutics 596 (2021), p. 120248.CrossRefGoogle Scholar