A direct LA-ICP-MS screening of elemental impurities in pharmaceutical products in compliance with USP and ICH-Q3D

Author:

Pluháček Tomáš,Ručka Michael,Maier VítězslavORCID

Funder

Ministry of Education, Youth and Sports of the Czech Republic

Publisher

Elsevier BV

Subject

Spectroscopy,Environmental Chemistry,Biochemistry,Analytical Chemistry

Reference20 articles.

1. The National Formulary, USP 37-NF32;United States Pharmacopeia,2012

2. ICH Q3D Step 4 - Guideline for Elemental Impurities;International Conference on Harmonisation,2014

3. Recent advances in the determination of elemental impurities in pharmaceuticals - status, challenges and moving frontiers;Balaram;Trac. Trends Anal. Chem.,2016

4. Impact and practicability of recently introduced requirements on elemental impurities;Pohl;Trac. Trends Anal. Chem.,2018

5. An overview of recent applications of inductively coupled plasma-mass spectrometry (ICP-MS) in determination of inorganic impurities in drugs and pharmaceuticals;Rao;J. Pharm. Biomed. Anal.,2007

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