GMP Purification of [14C] API

Our GMP purification and packaging services for [14C] API products are performed in state-of-the-art GMP suites. The GMP purification process includes the following:

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  • Complete replacement of all wetted surfaces in the preparative HPLC system
  • Never-before-used HPLC preparative or semi-preparative columns
  • Blank injection to verify the absence of contaminants in the system
  • Purification of the [14C] API to provided specifications
  • Aliquot preparation and packaging according to provided specifications
  • HPLC, MS, and NMR Analyses of the purified material utilizing qualified instrumentation
  • Availability of additional analyses
  • Appropriate temperature storage and tracking – free of charge for the first year
  • Shipment to domestic and international destinations upon request
  • Stability studies available on the purified material
  • A minimum of weekly updates via email or teleconference