Moravek is licensed by the California Department of Public Health, Food and Drug Branch for the preparation of 13C-labeled active pharmaceutical ingredients (APIs). In addition, Moravek is allowed to handle schedule I-V classified compounds under DEA authority.
Moravek provides quality carbon-13 labeling services that are compliant with good laboratory practices (GLP). The GLP 13C labeling process begins with a conversation between you and Moravek radiochemistry specialists. The project scope of work and scheduling will all be discussed. We will address all elements essential to your project to ensure the success of your GLP carbon-13 labeled compound.
GLP Carbon-13 Labeling Solutions Offered by Moravek
- GLP 13C-labeled Compound Manufacturing
Suitable for pre-clinical trials - Technical Batch Synthesis (optional)
Used to confirm synthetic pathway and establish stable labeled compound stability - Analytical Services and Purification
NMR of various nuclides, MS, GC/MS, LC/MS, HPLC, UHPLC, and Karl Fischer analyses performed on qualified instrumentation (other analytical services may be available upon request) - Temperature Controlled Stability Studies
NIST traceable temperature recording at ambient, +4°C, -20°C, or -80°C and analysis utilizing qualified HPLC or UHPLC systems - Comprehensive Logistics Services
Storage, chain of custody, dispensing, worldwide shipping, and temperature tracking
Production of GLP 13C-labeled compounds includes, but is not limited to:
Quality Systems
- Synthesis, purification, and testing in accordance with GLP
- Analytical method transfer (optional)
Production
- Synthesis carried out in a clean, dedicated fume hood
- Clean or new glassware for synthesis
Analysis & Documentation
- Certificate of Analysis certifying 13C-labeled product was produced in accordance with GLP
- HPLC, MS, and NMR analysis (as appropriate)
- TSE/BSE statement (optional)
- Copy of notebook pages* (including reagent sources, lot numbers, and 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 and international door-to-door shipment
- Secure storage at ambient, +4°C, -20°C, or -80°C
- Temperature logging during shipment (optional)
*Products manufactured under GLP are not suitable for use in humans.