Custom GLP Synthesis with Carbon 14 [14C]

Permitted to handle schedule I-V classified compounds under DEA authority and licensed by the Food and Drug Branch of the California Department of Public Health, Moravek paves the way in the preparation of GLP manufacturing and 14C labeling of active pharmaceutical ingredients (API)*.

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The GLP manufacturing process begins with a conversation between you and Moravek radiochemistry specialists. Whether you require custom GLP synthesis with carbon 14 or a temperature-controlled stability study, our expert radiochemists go over the top to ensure the success of your GLP [14C] project.

GLP [14C] Solutions Offered by Moravek

  • GLP [14C] Manufacturing
    Including custom GLP synthesis with carbon 14
  • Technical Batch Synthesis (optional)
    Used to confirm synthetic pathway and establish radiolabeled compound stability
  • GLP Analytical Services and GLP Purification of [14C] Compounds
    NMR of various nuclides, MS, HPLC, UPLC, and Karl Fischer analyses performed on qualified instrumentation (other analytical services also available)
  • Temperature Controlled Stability Studies
    NIST traceable temperature recording at +4, -20, and -80°C utilizing qualified HPLC systems
  • Comprehensive Logistics Services
    Storage, chain of custody, dispensing, shipping to worldwide locations, and temperature tracking.

Production of GLP [14C] Compounds includes, but is not limited to:

Quality Systems

  • Synthesis, purification and testing in accordance with GLP practices
  • Analytical method transfer (optional)

Quality Systems

  • Synthesis carried out in a clean, dedicated fume hood
  • Clean or new glassware for synthesis)

Analysis & Documentation

  • CoA certifying 14C product was produced in accordance with GLP practices
  • HPLC, MS, & NMR analysis (as appropriate)
  • SE/BSE statement (optional)
  • Copy of notebook pages* (incl. reagent sources, lot numbers & procedures)
    *notebook pages will not include proprietary information
  • Radiochemical and/or chemical stability data (optional)
  • Utilization of qualified analytical equipment

Logistics & Customer Service

  • Weekly email updates
  • Weekly teleconferences (optional)
  • Initial (kick-off) teleconference
  • Confirmation of storage/packaging conditions
  • Shipping & storage tracking

Shipping & Storage

    • Aliquot preparation
    • Domestic & International door-to-door shipment
    • Secure storage at ambient, +4°C, -20°C, or -80°C
    • Temperature logging during shipment (optional)

* Products produced under GLP guidelines are not suitable for clinical trials