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Synthesis of cGMP intermediates and APIs
In house we will produce up to 5.0 Kg. For quantities larger than 5.0 Kg. OrgSyn laboratory, will liaise with larger scale FDA approved manufacturers overseas. Each delivery will include batch records and full reports for synthetic preparations and analytical methods.
Infrastructure and Analytical Capabilities
- TSP HPLC
- Agilent HPLC
- Waters preparative HPLC
- Agilent GC
- Polarimeter
- Hydrogenators
- 20L and 10L rotary evaporators
- 50L, 22L and 12L reactors with -20°C to 150°C temperature range capabilities.
- Circulating cooling and heating baths
- Drying vacuum ovens
- Walk-in hoods
- NMR, Mass Spec, IR capabilities
- SciFinder and Beilstein
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An experienced quality assurance team constantly monitors the production and quality control operations to ensure that the highest quality APIs and advanced intermediates are produced under cGMP.
- Services in analytical method development and validation of HPLC and GC methods for intermediates and APIs
- Easy access to NMR, Mass Spectroscopy, XRD, digital polarimeter and IR of University of Illinois
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