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Process Development

The Process Development Department at PharmaChem functions in a newly renovated Process Development Lab (942 sq. ft.) equipped for small and large scale reactions, and a kilo lab (412 sq. ft.) used primarily for batch scale-up. Our efforts focus on multi-product process transfers, process familiarizations and process optimizations. With an assortment of equipment at our disposal, major listings include:

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  • UPLCs

  • Certified Fume Hoods

  • Buchi Rotary Evaporators

  • Julabo Re-Circulating Chillers (- 35°C to 110°C)

  • 20 L jacketed reactor

  • 60 L jacketed reactor

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Analytical Development and Quality Control

Analytical Development and Quality control laboratory occupies approximately 3,500 sq. ft., and uses NuGenesis Laboratory Management System. Laboratory capabilities include:

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  • Chromatography

    • HPLC and UPLC equipped with a variety of detectors including UV, DAD, CAD, and LC/MS

    • GC equipped with FID and TCD detectors, Headspace capabilities

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  • Particle Size Analysis (Malvern)

  • DSC

  • Karl Fisher (Coulometric and Volumetric)

  • Wet Chemistry

  • Software Systems (21 CFR part 11 compliant)

    • Empower Enterprise Chromatography Data System

    • LabX Laboratory Software package

    • NuGenesis LMS

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