Elemental Impurities: Getting from Risk Assessment to Regulatory Submission
Taking the next steps from risk assessment through method development, method validation and testing to the updating of an annual report or including elemental impurity data in a new regulatory submission.
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Risk Assessment and Testing Requirements for Elemental Impurities in Pharmaceutical Products
Understanding and developing strategies for risk assessment and analytical testing to ensure compliance with the requirements of ICH Q3D, Guideline for Elemental Impurities, USP , “Elemental Impurities, Limits,” and USP , “Elemental Impurities, Procedures.”
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Elemental Impurity Testing
Advances in elemental impurity testing aid compliance with new USP requirements
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ELEMENTAL IMPURITIES: A VIRTUAL COMPANY PERSPECTIVE
A look at risk assessments for elemental impurity determinations in oral tablet and parenteral drug products. Read More >>
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