Moravek is able to perform GLP synthesis, purification and testing in accordance with GLP practices.
Radiolabeled APIs produced or purified under GLP conditions are analyzed on IQ\OQ analytical instrumentation and may be supplied with a complete batch record, which includes documentation of the synthetic*, purification and analytical processes from start to finish.
*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.
Products produced under GLP conditions are analyzed using IQ\OQ HPLC and MS instrumentation and NMR.
Production of GLP materials includes, but is not limited to:
- Synthesis, purification and testing in accordance with GLP practices
- Analytical method transfer (optional)
- 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 analytical equipment with current IQ/OQ
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)