Moravek is licensed by the California Department of Public Health, Food and Drug Branch, for the preparation of 15N labeling of active pharmaceutical ingredients (API) for clinical trials*. In addition, Moravek is allowed to handle schedule I-V classified compounds under DEA authority.
Moravek provides custom synthesis, purification, and analysis of nitrogen-15 labeled compounds. The non-GLP [15N]-labeled compound manufacturing process begins with a conversation between you and Moravek’s expert chemists. 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 [15N]-labeled compound.
non-GxP [15N] Solutions Offered by Moravek
- Custom non-GLP 15N Labeling
- Non-GLP Analysis and Purification of 15N-labeled Compounds
NMR of various nuclides, MS, GC/MS, LC/MS, HPLC, UPLC and Karl Fischer analyses (other analytical services available, please inquire) - Temperature-Controlled Stability Studies
NIST traceable temperature recording at +4, -20 and -80°C (optional) - Comprehensive Logistics Services
Storage, chain of custody, dispensing, shipping to worldwide locations and temperature tracking (optional).
Production of non-GLP Nitrogen-15 Labeled Compounds includes, but is not limited to
Analysis & Documentation
- Certificate of Analysis certifying 15N product meets the agreed upon specifications
- HPLC, MS, & NMR analysis (as appropriate)
- Chemical stability data (optional)
- Utilization of qualified analytical equipment (optional)
Logistics & Customer Service
- Weekly email updates
- Initial (kick-off) teleconference (optional)
- 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)
* Products produced under non-GMP guidelines are not suitable for clinical trials