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Be Sure in Pharmaceutical Impurities Analysis

Be Sure in Pharmaceutical Impurities Analysis

To ensure product purity, you need techniques and technologies that deliver fast answers without sacrificing data quality. Count on Agilent innovations to streamline your analysis and enable accurate, reproducible results.

Chemical synthesis, scale-up, and manufacturing processes can result in a wide range of impurities that remain with active pharmaceutical ingredients or drug product formulations. Even in trace amounts, these impurities can negatively impact your final product. Therefore, identifying and quantifying impurities is critical to product quality—and subject to stringent regulatory restrictions.

Extractables & leachables

Frustrated with the complex challenges of analyzing extractables and leachables?

Our proven analytical instruments, software, libraries, and databases enable you to analyze a broad range of compounds. So, you can be confident that container and packaging impurities will not contaminate the drugs inside.

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Elemental analysis

Are you ready for updated regulatory standards for controlling elemental impurities?

New USP and ICH chapters require more elements to be monitored at lower levels than ever before. Innovative Agilent instrumentation, software tools, qualification, and compliance services can help you meet these guidelines.

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Residual solvents

Can you streamline your residual solvent analysis and still meet stringent regulatory requirements?

Solvents must be removed as completely as possible to meet product specifications and good manufacturing practices. The Agilent Intuvo system, equipped with a headspace sampler, can simplify your USP <467> compliant residual solvent analysis.

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HCPs

Need to analyze host cell proteins faster, without sacrificing data quality or spectral resolution?

Because HCPs can be detrimental to drug safety and efficacy, you must carefully monitor and control their levels, according to regulatory requirements. Count on innovative Agilent techniques, technologies, and services to deliver reproducible results and streamline your workflow.

Additional resources

Need proven strategies for analyzing organic, inorganic, and elemental impurities?

Our free primer offers Agilent solutions for identifying and quantifying three major categories of pharmaceutical impurities—plus an outline of regulations that govern the industry.

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