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Pharma & Biopharma
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Measuring Elemental Impurities in Pharmaceutical Materials
2022|Agilent Technologies|Brochures and specifications
Measuring Elemental Impuritiesin Pharmaceutical MaterialsAgilent Atomic Spectroscopy Solutions USP <232>/<233> & ICH Q3D(R2)/Q2(R1)Implementing Elemental Impurities Tests in thePharmaceutical IndustryWorldwide regulations for pharmaceutical materialsWorldwide pharmacopeias have introduced revisedstandards for controlling elemental impurities in drugproducts and ingredients. The current USP and ICHchapters require...
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Application NotePharmaceuticalElemental Impurities in Aspirin: USP<232>/<233> and ICH Q3D MethodsUsing ICP-OESValidation of the USP <232>/<233> method on anAgilent ICP-OESAuthorLindsey Whitecotton, GregGilleland, Elizabeth Kulikov, andAmir LibaAgilent Technologies, Inc., USASamina HussainExova, USAIntroductionPharmaceutical manufacturers are required to control elemental impurities in drugproducts. Sources...
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Proposed new ICH and USP methods forelemental impurities: The application ofICP-MS and ICP-OES for pharmaceuticalanalysisWhite paperAuthorsAmir Liba, Ed McCurdy andRoss AshdownAgilent TechnologiesAbstractThe United States Pharmacopeial Convention (USP), in parallel with theInternational Conference on Harmonisation (ICH), is developing newmethods for inorganic...
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White PaperUSP <232>/<233> and ICH Q3DElemental Impurities Analysis:The Agilent ICP-OES SolutionElemental Impurity Analysis RequirementsWorldwide, regulatory authorities are responsible for ensuring thatpharmaceutical products are both effective and safe. To achieve this, potentiallyharmful contaminants—including elemental impurities—must be identified, andlimits defined for the...
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