Moravek, Inc. is licensed by the Food and Drug Branch of the California Department of Public Health for the preparation of 14C, 3H, or 35S labeling of active pharmaceutical ingredients (API) for research. We are also permitted to handle schedule I-V classified compounds under DEA authority.
Moravek, Inc. performs good laboratory practice (GLP) synthesis, purification, and testing of radiolabeled compounds in strict accordance with GLP guidelines. Our expert chemists analyze radiolabeled APIs that have been produced or purified under GLP conditions on qualified analytical instrumentation. Complete batch records with documentation of the synthetic*, purification and analytical processes from start to finish may be included as well.
*notebook pages containing proprietary information will not be disclosed
Finished 14C, 3H and 35S radiolabeled APIs can be sent to a contract research laboratory (CRO), to carry out testing.
GLP work is carried out in a clean, dedicated fume hood.
- Finished 14C, 3H, and 35S radiolabeled APIs can be sent to a contract research laboratory (CRO) for further testing.
- All good laboratory practice (GLP) work is carried out in a clean, dedicated fume hood.
- Products produced under GLP conditions are analyzed using qualified HPLC and MS instrumentation and NMR.
Production of GLP materials 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 14C, 3H or 35S product was produced in accordance with GLP practices
- 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 - 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)