Pharmaceutical Technology-09-02-2014

Ultrasonic cleaning of solid-dosage tooling and other equipment, such as filling-machine valves and nozzles, is more effective than hand cleaning.

Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.

A survey of the recent literature reveals numerous advances in asymmetric chemocatalysis.

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

The Waters Xevo G2-XS mass spectrometer is a new high-performance benchtop quadrupole time-of-flight (QTof) mass spectrometer that combines the new XS Collision Cell with the technologies of Tof-MRM, StepWave and QuanTof for sensitivity and selectivity that allows detection of low-level compounds.

The ADP600 Series high accuracy Peltier temperature-controlled polarimeters from Xylem?s Bellingham + Stanley brand measure chiral compounds and other optically active substances.

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Innovations in drug delivery such as needle-free transfer devices and vial adapters can provide consistency when transferring liquid for reconstitution of lyophilized drug products.

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.

Thermo Fisher Scientific's Vanquish ultra-high performance liquid chromatography (UHPLC) system is a new design for improved productivity and usability when used as a standalone system or with the latest mass spectrometers.

The MA3100 high performance ion mobility pre-separator (HPIMS) from Excellims has been built to interface with multiple mass spectrometer (MS) product lines from Thermo Fisher Scientific.

With a quality-by-design approach, robust processes consistently can help deliver quality product.

Flexibility, which involves the ability to quickly change product capacity or even product type to meet market demand, is increasingly important. In new construction or renovation, modular process skids and modular buildings create this flexibility. Experts discuss trends and challenges.

Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.

FDA demands accurate manufacturing and test information to ensure product quality.

The role of add-on devices and how they affect drug delivery with a pressurized metered dose inhaler.

Annual study shows geographic proximity not a factor in CMO selection.

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