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Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLCThe authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
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Mineral Salts Low in EndotoxinsDr. Paul Lohmann’s production unit was finalized in March 2017, allowing the manufacturer to comply with quality and regulatory requirements, and satisfy increasing volume demands for minerals in parenteral applications.
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Midilab RCMidilab RC is Diosna’s modular laboratory equipment that offers a fluid bed and a tablet coater module for a flexible production. Different batch sizes and a rapid change between the modules are just some of the benefits.
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CordenPharma International GmbHCordenPharma is your full-service CDMO partner for APIs, Drug Products, and Packaging Services.
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A Perspective on the Topical Delivery of MacromoleculesThe human skin protects the body from physical, mechanical, and chemical insults while preventing endogenous water loss. This function is predominantly achieved by a thin (10–30 µm) cornified outermost layer-the stratum corneum (SC)-generated through terminal differentiation of the basal epidermal keratinocytes. The stratum corneum protects the human body, but also severely limits drug delivery into and across the skin.
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Process Development Best Practices for Topical Drug ProductsUsing a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.
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Identifying TPPs and CQAs for a Lyophilized Parenteral ProductQuality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.
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Residual Moisture Testing Methods for Lyophilized Drug ProductsUnderstanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials--and the respective limitations--aids in selecting the most appropriate method for testing.
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How to Plan Smoke StudiesAirflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.
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Integrated Systems Aid Data IntegrityIntegrated computerized systems for data collection improve data security and offer a solution for handling temporary data.
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Integrated Systems Aid Data IntegrityIntegrated computerized systems for data collection improve data security and offer a solution for handling temporary data.
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Time to GAIN: Are Your FDA Marketing Exclusivities Eligible for Extension?Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.
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Time to GAIN: Are Your FDA Marketing Exclusivities Eligible for Extension?Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.
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Time to GAIN: Are Your FDA Marketing Exclusivities Eligible for Extension?Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Developing New Mass Spectrometry Solutions: From Individual Membrane Protein Complexes to In-Vivo Proteome DynamicsHigh speed MALDI mass spectrometry instrumentation drives multidisciplinary membrane proteomics research.
