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Proposed new ICH and USP methods for elemental impurities: The application of ICP-MS and ICP-OES for pharmaceutical analysis

 

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White Paper USP <232>/<233> and ICH Q3D Elemental Impurities Analysis: The Agilent ICP-MS Solution Elemental Impurity Analysis Requirements Worldwide, regulatory authorities are responsible for ensuring that pharmaceutical products are both effective and safe. Potentially toxic and harmful contaminants—including elemental impurities—must…
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White Paper USP <232>/<233> and ICH Q3D Elemental Impurities Analysis: The Agilent ICP-OES Solution Elemental Impurity Analysis Requirements Worldwide, regulatory authorities are responsible for ensuring that pharmaceutical products are both effective and safe. To achieve this, potentially harmful contaminants—including elemental…
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Application Note Pharmaceuticals Validating performance of an Agilent ICP‑MS for USP <232>/<233> & ICH Q3D(R2)/Q2(R1) Reducing the time and expense of ICP-MS method development and system validation for measuring elemental impurities in pharmaceuticals Authors Lindsey Whitecotton, Ed McCurdy, Craig Jones…
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Measuring Elemental Impurities in Pharmaceutical Materials
2022|Agilent Technologies|Brožury a specifikace
Measuring Elemental Impurities in Pharmaceutical Materials Agilent Atomic Spectroscopy Solutions USP <232>/<233> & ICH Q3D(R2)/Q2(R1) Implementing Elemental Impurities Tests in the Pharmaceutical Industry Worldwide regulations for pharmaceutical materials Worldwide pharmacopeias have introduced revised standards for controlling elemental impurities in drug…
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pde, pdeelemental, elementalqualification, qualificationimpurities, impuritiesyou, youyour, yourcrosslab, crosslabagilent, agilentparenteral, parenteralcompliance, compliancecrms, crmssoftware, softwareich, ichhave, haveinhalational
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