GMP Carbon-14 Radiolabelled APIs and IMPs

Lab workers in protective gear

GMP Carbon-14 Radiolabelled APIs and IMPs Services

Pharmaron provides GMP-compliant services for the synthesis, purification and analysis of radiolabelled drug substance (API), and subsequent preparation of drug product (IMP) for use in clinical studies. Our GMP manufacturing suites are available to facilitate multiple GMP radiosynthesis projects in parallel. Five successful UK MHRA facility audits have been conducted since 2004.

  • GMP synthesis of 14C radiolabelled APIs includes polymer dispersions and spray-dried dispersions
  • GMP manufacturing of 14C radiolabelled IMP – drug product for oral administration: solutions, suspensions, solids for reconstitution (‘drug in bottle’), hard shell capsules
  • GMP QC laboratories
  • QA release of GMP 14C radiolabelled API
  • QC capabilities: MS, LSC, HP(UP)LC, CAD, NMR, GC, dissolution, TGA, KF, XRPD, endotoxin testing
  • Dedicated project manager per project
  • Qualified Person release of 14C radiolabelled IMP
  • Support for preparation of regulatory documentation
  • Worldwide shipping of radiolabelled compounds

Download PDF to learn more about Pharmaron’s Manufacture of 14C Radiolabelled Drug Substances and Drug Products for Clinical Studies.

pdf download for manufacture of carbon-14