Determination of ICH class 1 and class 2A trace elements in Triheptanoin oral liquid for long-chain fatty acid oxidation disorders, an ICP-MS approach

Abstract Elemental impurities in pharmaceutical products pose significant safety concerns and are strictly regulated under ICH Q3D (R2) guidelines. This study presents a validated method for the quantitative determination of ICH Class 1 (As, Cd, Hg, Pb) and Class 2A (V, Co, Ni) elemental impurities...

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Autori principali:	Mehar Raghavendra Yeggina, Krishnamanjari Pawar Amgoth
Natura:	Artigo
Lingua:	Inglês
Pubblicazione:	Springer 2025-10-01
Serie:	Discover Chemistry
Soggetti:	Inductively coupled Plasma-Mass spectrometry Elemental impurities Triheptanoin oral liquid Long-chain fatty acid oxidation disorders Permitted daily exposure
Accesso online:	https://doi.org/10.1007/s44371-025-00302-z
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