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 GLP tritium synthesis 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 tritium synthesis project’s success will be considered in order to arrive at an appropriate scope of work. Our team strives to ensure the success of your tritium synthesis project with our proactive project management and state-of-art equipment and facilities.
GLP [3H] Solutions Offered by Moravek
- GLP [3H] Manufacturing
- Technical Batch Synthesis (optional)
Used to confirm synthetic pathway and establish radiolabeled compound stability - GLP Analytical Services and GLP Purification of [3H] Compounds
Tritium NMR, and MS, GC/MS, LC/MS, HPLC and UPLC 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 tritium-labeled compounds includes, but is not limited to:
Quality Systems
- GLP [3H] Manufacturing
- Analytical method transfer (optional)
Production
- Tritium synthesis carried out in a clean, dedicated fume hood
- Clean or new glassware for synthesis
Analysis & Documentation
- CoA certifying 3H product was produced in accordance with GLP practices
- 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)