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eBookeBook-Small Molecule Analytical Chemistry The Importance of assessing Elemental Impurities |
Understanding and developing strategies for risk assessment and analytical testing to ensure compliance with the new requirements of ICH 3QD, Guideline for Elemental Impurities, USP <232>, “Elemental Impurities, Limits,” and USP <233>, “Elemental Impurities, Procedures.” Using our extensive experience of elemental impurity testing, we will guide you through the ICH Q3D and USP <232> and <233> requirements, developing a tailored package of analysis to ensure you comply with regulatory guidelines.
Learn more about:
Determination in inorganic elements
Protocol Design
Investigative Screening Analysis
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Catalyst + Talent
Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 17,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.
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