Application of X-ray fluorescence spectrometry for screening pharmaceutical products for Elemental Impurities according to ICH guideline Q3D-Reference-Cited by-同舟云学术

Application of X-ray fluorescence spectrometry for screening pharmaceutical products for Elemental Impurities according to ICH guideline Q3D

Published:2020-02 Issue: Volume:179 Page:113005
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Sauer Benjamin,Xiao Youhong,Zoontjes Michel,Kroll Christian

Funder

Malvern Panalytical

Publisher

Elsevier BV

Subject

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

Reference24 articles.

1. International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guideline for Elemental Impurities Q3D(R1),2019

2. 20408 (07/2010), Eur. Pharmacop. 9.0. (2010).

3. Elemental impurities in pharmaceutical excipients;Li;J. Pharm. Sci.,2015

4. Aaron Hineman; Ken Neubauer, Meeting the USP <232> and <233> Guidelines with ICP-OES, Spectrosc. (Santa Monica). 33 (2018) 8–15.

5. Determination of Elemental Impurities in Antacids by ICP-MS According to the Validation Protocols Defined in USP Chapters <232> and <233> and ICH Q3D Step 4 Guidelines;Hineman;Spectrosc. (Santa Monica),2017

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