Custom Synthesis with Carbon 13 [13C]

Moravek is licensed by the California Department of Public Health, Food and Drug Branch, for the preparation of 13C labeling of active pharmaceutical ingredients (API) for clinical trials*. In addition, Moravek is allowed to handle schedule I-V classified compounds under DEA authority.

The non-GxP [13C] product manufacturing process begins with a conversation between you and Moravek Chemistry specialists. Project scope of work and scheduling are all discussed. All elements essential to your project’s success will be discussed in order to arrive at an appropriate scope of work and to ensure the success of your custom [13C] project.

non-GxP [13C] Solutions Offered by Moravek

  • Custom non-GxP [13C] Manufacturing
    non-GxP Analytical Services and non-GxP Purification of [13C] Compounds

    NMR of various nuclides, MS, GC/MS, LC/MS, HPLC, UPLC and Karl Fischer analyses (Other analytical services 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 [13C] Compounds includes, but is not limited to:

Analysis & Documentation

  • CoA certifying 13C product meets the agreed upon specifications
  • HPLC, MS, & NMR analysis (as appropriate)
  • 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