Moravek specializes in the custom manufacture of GMP carbon-14 labeled active pharmaceutical ingredients (APIs) intended for use in early phase clinical trials. Moravek also offers custom non-GMP manufacturing of 14C-labeled compounds and an extensive catalog containing many non-GLP 14C-labeled compounds to suit a wide variety of research needs.
Experience
Since 1980, Moravek has successfully manufactured over 2,000 14C-labeled products. Our knowledgeable radiochemists are skilled in many laboratory techniques and chemical reactions and are able to synthesize nearly any compound, including the full range of U.S. Drug Enforcement Administration Schedule I – V controlled substances. Supported by decades of experience, we can develop an efficient radiosynthesis pathway to incorporate one or more carbon-14 label(s) into your custom compound. We can recommend a carbon-14 label position and we may be able to offer multiple options for label positions.
Custom Manufacturing Process
Production of carbon-14 labeled compounds typically includes synthesis and HPLC purification, as well as any final steps to convert the product to the desired final form, including but not limited to:
- Crystallization
- Salt formation or removal
- Dilution with non-labeled material
- Dissolution
- Lyophilization
Upon completion of the production process, analysis of the final product is performed according to the agreed-upon reportable testing and then a Certificate of Analysis is provided.
The logistics of your project will be managed by our talented customer service staff. A project manager will be assigned to your project and will provide periodic email updates, answer your questions, and keep your project on track.