The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation

References

1. 1.↵
   Product Quality Research Institute. Safety Thresholds and Best Practices for Extractables and Leachables In Orally Inhaled and Nasal Drug Products, 2006. PQRI Web site. http://pqri.org/wp-content/uploads/2015/08/pdf/LE_Recommendations_to_FDA_09-29-06.pdf (accessed March 7, 2021).
2. 2.↵
   International Conference for Harmonisation, Quality Guideline M7(R1): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. ICH: Geneva, 2015.
3. 3.↵
   1. Mellon D

   . Nonclinical Review of Extractable Leachables Studies: Practical Advice for an FDA Reviewer. Presented at Smithers Rapra Extractables & Leachables USA 2019 Conference, Arlington, VA, May 9, 2019.
4. 4.↵
   International Organization for Standardization, ISO/TS 21726:2019 Biological Evaluation of Medical Devices—Application of the Threshold of Toxicological Concern (TTC) for Assessing Biocompatibility of Medical Device Constituents. ISO: Geneva, 2019.
5. 5.↵
   1. Norwood D. L.,
   2. Nagao L. M.

   The Analytical Evaluation Threshold (AET), 2005. PQRI Web site. http://pqri.org/wp-content/uploads/2015/08/pdf/PQRI_AET_Poster.pdf (accessed March 7, 2021).
6. 6.↵
   1. Jordi M. A.,
   2. Khera S.,
   3. Roland K.,
   4. Jiang L.,
   5. Solomon P.,
   6. Nelson J.,
   7. Lateef S. S.,
   8. Woods J.,
   9. Martin L.,
   10. Martin S.,
   11. Aiello F.,
   12. Chen N.

   Qualitative Assessment of Extractables from Single-Use Components and the Impact of Reference Standard Selection. J. Pharm. Biomed. Anal. 2018, 150, 368–376.
7. 7.↵
   International Organization for Standardization, ISO 10993-18:2020 Biological Evaluation of Medical Devices—Part 18: Chemical Characterization of Medical Device Materials Within A Risk Management Process. ISO: Geneva, 2020.
8. 8.↵
   1. Mullis J. O.,
   2. Granger A.,
   3. Quin C.,
   4. Norwood D. L.

   The Analytical Evaluation Threshold (AET) Concept, Sensitivity and Analytical Uncertainty. Presented at the Smithers Rapra Leachables and Extractables 2008 Conference, Dublin, Ireland, March 5–6, 2008.
9. 9.
   1. Jenke D.,
   2. Odufu A.

   Utilization of Internal Standard Response Factors to Estimate the Concentration of Organic Compounds Leached from Pharmaceutical Packaging Systems and Application of Such Estimated Concentrations to Safety Assessment. J. Chromatogr. Sci. 2012, 50 (3), 206–212.

   OpenUrlCrossRefPubMed
10. 10.↵
    1. Zdravkovic S. A.,
    2. Duong C. T.,
    3. Hellenbrand A. A.,
    4. Duff S. R.,
    5. Dreger A. L.

    Establishment of a Reference Standard Database for Use in the Qualitative and Semi-Quantitative Analysis of Pharmaceutical Contact Materials within an Extractables Survey by GC-MS. J. Pharm. Biomed. Anal. 2018, 151, 49–60.

    OpenUrl
11. 11.↵
    1. Christiaens P.,
    2. Beusen J. M.,
    3. Verlinde P.,
    4. Baeten J.,
    5. Jenke D.

    Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—The Errors of Inexact Identification and Inaccurate Quantitation. PDA J. Pharm. Sci. Technol. 2020, 74 (1), 108–133.

    OpenUrlAbstract/FREE Full Text
12. 12.↵
    1. Jordi M. A.,
    2. Rowland K.,
    3. Liu W.,
    4. Cao X.,
    5. Zong J.,
    6. Ren Y.,
    7. Liang Z.,
    8. Zhou X.,
    9. Louis M.,
    10. Lerner K.

    Reducing Relative Response Factor Variation Using a Multidetector System for Extractables and Leachables (E&L) Analysis to Mitigate the Need for Uncertainty Factors. J. Pharm. Biomed. Anal. 2020, 186, 113334.

    OpenUrl
13. 13.↵
    1. Jenke D.,
    2. Liu N.

    Chromatographic Considerations in the Standardization of Liquid Chromatographic Methods Used for Extractables Screening. J. Liq. Chromatogr. Relat. Technol. 2016, 39 (13), 613–619.

    OpenUrl
14. 14.↵
    1. Zdravkovic S.,
    2. Bruss M. D.,
    3. Piccoli R. F.,
    4. Wood D. M.

    A Method Utilizing Ultra-High Performance Liquid Chromatography with Ultraviolet and Mass Spectrometric Detection of the Analysis of Material Extracts Produced during a Controlled Extraction Study. PDA J. Pharm. Sci. Technol. 2014, 68 (5), 504–526.

    OpenUrlAbstract/FREE Full Text