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Determination of Eight Nitrosamine ImpuritiesThis application note demonstrates that the Agilent 6475 triple quadrupole LC/MS system can confidently quantify nitrosamine impurities at the low concentration levels specified by regulatory requirements. This method can be used to quantify these impurities in different ARB drug products, with some changes in chromatographic conditions based on the elution pattern of the drug product.
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Want Faster and Cheaper with Higher Quality? Get it Right the First TimeWeak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
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Want Faster and Cheaper with Higher Quality? Get it Right the First TimeWeak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
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CPhI Worldwide 2017Latest:
Improving Content Uniformity of Morphologically Challenging APIs by Excipient ChoiceWebinar Date/Time: Tues Jan 14, 2025 11:00 AM EST
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Treating Halogenated Hydrocarbon Emissions from Pharmaceutical ProductionRegenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems.
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Avoiding Investigational Failure/Discrepancy-Related Form 483 ObservationsInvestigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
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Speeding Time to Market With Better Pharmaceutical Project ManagementElevating the project management function can improve transparency and enable companies to react faster to internal and external change.
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Understanding the Potential of Artificial Intelligence Across the Pharmaceutical LifecycleArtificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.
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A Continuous Improvement Metric for Pharmaceutical ManufacturingStatistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
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Lifecycle-Based Process Validation Emphasizes the Need for Continued Process VerificationA year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
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Lifecycle-Based Process Validation Emphasizes the Need for Continued Process VerificationA year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
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A Continuous Improvement Metric for Pharmaceutical ManufacturingStatistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
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Avoiding Investigational Failure/Discrepancy-Related Form 483 ObservationsInvestigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
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Executive Summary: End-To-End Regulatory CDMO Solutions: Development, Manufacturing, and ApprovalThe road to market access is long and complex. Choosing a CDMO with experienced staff can prove vital to success. In this executive summary, Praveenkumar Devakadaksham and Dr. Roché Marcel Walliser explain all the ways they help make the journey from pharmaceutical development to commercial distribution as smooth as possible. Learn more about:
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Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
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Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
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Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
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Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
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Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
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Innovations Maintain the Cold ChainRecent advancements in cold-chain technology offer improved transporting and storing of temperature-sensitive pharmaceutical products.
