Custom Synthesis with Carbon 14 [14C]

Moravek is licensed by the Food and Drug Branch of the California Department of Public Health to prepare 14C, 3H, and 35S labeled active pharmaceutical ingredients for clinical trials. We are also permitted by the DEA to handle schedule I-V classified compounds.

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Non-GxP Custom Synthesis with Carbon 14C

The manufacturing process for non-GXP [14C] products begins with a conversation between you and our radiochemistry specialists. We discuss the project’s scope of work and scheduling, as well as all of the elements that are critical to your project’s success. In this way we aim to ensure the success of your custom 14C labeling or carbon 14 production project.

Moravek’s Non-GxP [14C] Solutions include:

Analysis & Documentation

  • Custom non-GxP [14C] manufacturing
  • Non-GxP analytical services and non-GxP purification of [14C] compounds
    NMR of various nuclides, MS, GC/MS, LC/MS, HPLC, UPLC, and Karl Fischer analyses (other analytical services are also available)
  • Temperature controlled stability studies (optional)
    NIST traceable temperature recording at +4, -20 and -80°C
  • Comprehensive logistics services
    Storage, chain of custody, dispensing, shipping to worldwide locations, and temperature tracking (optional)

Production of non-GxP [14C] Compounds includes, but is not limited to:

Analysis & Documentation

  • CoA certifying 14C product meets the agreed upon specifications
  • HPLC, MS, & NMR analysis (as appropriate)
  • Radiochemical and/or chemical stability data (optional)
  • Utilization of qualified analytical equipment (optional)

Logistics & Customer Service

  • Weekly email updates
  • Initial (kick-off) teleconference (optional)
  • 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 non-GMP guidelines are not suitable for clinical trials