Determination of elemental impurities in drugs products and active pharmaceutical ingredients by inductively coupled plasma mass spectrometry

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15310%2F18%3A73592310" target="_blank" >RIV/61989592:15310/18:73592310 - isvavai.cz</a>
Result on the web
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DOI - Digital Object Identifier
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Result language
angličtina
Original language name
Determination of elemental impurities in drugs products and active pharmaceutical ingredients by inductively coupled plasma mass spectrometry
Original language description
The aim of contract research were to develop and optimize methods for verification of the elemental impurities content by screening of heavy metals in pharmaceutical products and active pharmaceutical ingredients (APIs) according to ICH Q3D guideline. The research was focused on the following: the development and optimization of decomposition methods of pharmaceutical samples and the development and optimization of methods for subsequent determination of heavy metals in the pharmaceutical samples according to ICH Q3D guideline using inductively coupled plasma mass spectrometry (ICP-MS). The developed methods were validated and subsequently used for the determination of heavy metals according to the ICH Q3D guideline in the supplied drug products and APIs (4 drugs products and 15 APIs in total).
Czech name
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Czech description
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Publication year
2018
Confidentiality
C - Předmět řešení projektu podléhá obchodnímu tajemství (§ 504 Občanského zákoníku), ale název projektu, cíle projektu a u ukončeného nebo zastaveného projektu zhodnocení výsledku řešení projektu (údaje P03, P04, P15, P19, P29, PN8) dodané do CEP, jsou upraveny tak, aby byly zveřejnitelné.

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