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Custom GLP [15N] Labeling

Moravek is licensed by the California Department of Public Health, Food and Drug Branch, for the preparation of 15N labeling of active pharmaceutical ingredients (API) for clinical trials*. In addition, Moravek is allowed to handle schedule I-V classified compounds under DEA authority.
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Moravek offers custom stable-labeling of compounds with 15N, subject to good laboratory practices (GLP). The GLP 15N-labeled compound manufacturing process begins with a conversation between you and Moravek radiochemistry specialists. Project scope of work and scheduling will all be discussed in order to ensure the success of your GLP 15N-labeled compound.

GLP [15N] Solutions Offered by Moravek

  • GLP [15N] Manufacturing (optional)
  • Technical Batch Synthesis (optional)
    Used to confirm synthetic pathway and establish stable labeled compound stability
  • GLP Analytical Services and GLP Purification of [15N] Compounds
    NMR of various nuclides, MS, GC/MS, LC/MS, HPLC, UPLC and Karl Fischer analyses performed on qualified instrumentation. (Other analytical services 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 [15N] Compounds includes, but is not limited to:

Quality Systems

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

Production

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

Analysis & Documentation

  • CoA certifying 15N-labeled product was produced in accordance with GLP
  • 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
  • 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