Moravek is licensed by the California Department of Public Health, Food and Drug Branch, for the preparation of 3H 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 [3H] product manufacturing process begins with a conversation between you and Moravek radiochemistry 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 [3H] project.
non-GxP [3H] Solutions Offered by Moravek
- Custom non-GxP [3H] Manufacturing
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non-GxP Analytical Services and non-GxP Purification of [3H] Compounds
Tritium NMR, MS, GC/MS, LC/MS, HPLC and UPLC (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 [3H] Compounds includes, but is not limited to:
Analysis & Documentation
- CoA certifying 3H product meets the agreed upon specifications
- HPLC, MS, & tritium 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