Moravek is licensed by the California Department of Public Health, Food and Drug Branch, for the preparation, and stable labeling of active pharmaceutical ingredients (API) for research*. In addition, Moravek is allowed to handle schedule I-V classified compounds under DEA authority.
The stable-labeled compound manufacturing process begins with a conversation between you and chemists at Moravek. We will address all elements essential to your project’s success to arrive at an appropriate scope of work. Our team strives to ensure the success of your custom stable-labeled compound produced under research grade (non-GLP) conditions.
Production of GLP materials includes, but is not limited to:
Analysis & Documentation
- Certificate of Analysis certifying stable-labeled product meets the agreed upon specifications
- HPLC, MS, and 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 - Chemical stability data (optional)
- Utilization of qualified analytical equipment (optional)
Logistics & Customer Service
- Weekly email updates
- Initial (kick-off) teleconference
- Confirmation of storage and packaging conditions
- Shipping and 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 GLP guidelines are not suitable for clinical trials