Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables

Dennis Jenke

doi:10.5731/pdajpst.2019.010520

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Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables

Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 348-358; DOI: https://doi.org/10.5731/pdajpst.2019.010520

Dennis Jenke

Triad Scientific Solutions, LLC

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vol. 74 no. 3 348-358

DOI

https://doi.org/10.5731/pdajpst.2019.010520

PubMed

32295860

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online May 26, 2020.

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Dennis Jenke

Triad Scientific Solutions, LLC

Corresponding Author: Triad Scientific Solutions, LLC, 181 Peregrine Lane, Hawthorn Woods, IL 60047. Telephone (847) 393-3151; E-mail: dennisjenke{at}triadscientificsolutions.com

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Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables

Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 348-358; DOI: 10.5731/pdajpst.2019.010520

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Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 348-358; DOI: 10.5731/pdajpst.2019.010520

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A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation

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Keywords

Extractables
Leachables
Analytical Evaluation Threshold
Quantitation
Uncertainty Factor
Safety risk assessment

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Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables

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