Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation

Piet Christiaens; Jean-Marie Beusen; Philippe Verlinde; Jan Baeten; Dennis Jenke

doi:10.5731/pdajpst.2018.009779

Research ArticleTechnology/Application

Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation

Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 108-133; DOI: https://doi.org/10.5731/pdajpst.2018.009779

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vol. 74 no. 1 108-133

DOI

https://doi.org/10.5731/pdajpst.2018.009779

PubMed

31308065

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Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

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Published online February 3, 2020.

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Piet Christiaens¹,
Jean-Marie Beusen¹,
Philippe Verlinde¹,
Jan Baeten¹ and
Dennis Jenke¹,*

¹Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium

↵* Corresponding Author: Triad Scientific Solutions, LLC, 181 Peregrine Lane, Hawthorn Woods, IL 60047; Telephone: (1)-847-393-3151; e-mail: dennisjenke{at}triadscientificsolutions.com

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Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation

Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten, Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 108-133; DOI: 10.5731/pdajpst.2018.009779

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Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation

Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten, Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 108-133; DOI: 10.5731/pdajpst.2018.009779

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The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables
Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3--Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices

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Keywords

Extractables
Leachables
Chromatographic analysis
Screening analysis
Identification
Database
Quantitation
Internal standard
Response factor

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