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 offers custom stable-labeling of compounds with 15N, subject to good laboratory practices (GLP). The GLP 15N-labeled compound manufacturing process begins with a conversation between you and Moravek radiochemistry specialists. Project scope of work and scheduling will all be discussed in order to ensure the success of your GLP 15N-labeled compound.
GLP [15N] Solutions Offered by Moravek
- GLP [15N] Manufacturing (optional)
- Technical Batch Synthesis (optional)
Used to confirm synthetic pathway and establish stable labeled compound stability - GLP Analytical Services and GLP Purification of [15N] Compounds
NMR of various nuclides, MS, GC/MS, LC/MS, HPLC, UPLC and Karl Fischer analyses performed on qualified instrumentation. (Other analytical services available) - Temperature Controlled Stability Studies
NIST traceable temperature recording at +4, -20 and -80°C utilizing qualified HPLC systems - Comprehensive Logistics Services
Storage, chain of custody, dispensing, shipping to worldwide locations and temperature tracking.
Production of GLP [15N] Compounds 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 15N-labeled product was produced in accordance with GLP
- 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 - 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)
*Products produced under GLP guidelines are not suitable for clinical trials