Reducing relative response factor variation using a multidetector approach for extractables and leachables (E&L) analysis to mitigate the need for uncertainty factors

Author:

Jordi Mark Anderson,Rowland Kevin,Liu Weixi,Cao Xingluan,Zong Jie,Ren Yuan,Liang Zhu,Zhou Xiao,Louis Michael,Lerner Kaitlin

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference30 articles.

1. Q2(R1) Validation of Analytical Procedures: Text and Methodology;International Conference on Harmonisation,2020

2. Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology;Food and Drug Administration,1996

3. USP <661.2> Plastic Packaging Systems for Pharmaceutical Use;United States Pharmacopeia,2020

4. USP 40 General Chapter Assessment of Extractables Associated With Pharmaceutical Packaging/Delivery Systems <1663>,2017

5. USP 40 General Chapter Assessment of Drug Product Leachables Associated With Pharmaceutical Packaging/Delivery Systems. <1664>,2017

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