Custom GLP Synthesis of [14C]-labeled Compounds

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 provides exceptional GLP manufacturing and 14C labeling of active pharmaceutical ingredients (API)**.

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The good laboratory practice (GLP) manufacturing process for 14C-labeled compounds 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 above and beyond to ensure the high quality and timely production of your custom 14C-labeled compound manufactured under good laboratory practices.

GLP [14C] Labeling Solutions Offered by Moravek

  • GLP [14C]-labeled Compound Manufacturing
  • 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, UHPLC, and Karl Fischer analyses performed on qualified instrumentation (other analytical services also available, please inquire)
  • Temperature-Controlled Stability Studies Storage in ambient, +4°C, -20°C, and -80°C with NIST traceable temperature recording and analysis with qualified HPLC or UHPLC 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
  • Analytical method transfer (optional)
  • Synthesis carried out in a clean, dedicated fume hood
  • Clean or new glassware for synthesis

Analysis & Documentation

  • Certificate of Analysis CoA certifying 14C-labeled product was manufactured in accordance with GLP practices.
  • HPLC, MS, & NMR analysis (as appropriate)
  • TSE/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