Exceptional results from a controlled approachA specialist in the preparation of C-14 radiolabelled API for clinical studies, we operate in compliance with EMEA and FDA Phase 1 GMP guidelines

Radiolabelled API to GMP Concepts

Selcia has prepared a number of C-14 radiolabelled APIs on behalf of clients for Phase I, mass balance and microdosing (phase 0 and enhanced Phase I) studies.


Whether you require a repurification of pre-clinical material under GMP concepts or a new synthesis under GMP concepts we perform both in compliance with EMEA and the recent FDA Phase I GMP guidance (IQCH Q7A Section 19: Single batches for investigational drugs).

The radiolabelled API is analysed in Selcia’s MHRA accredited GLP analytical laboratory and supplied with a complete analytical data package. Selcia will also assist you in providing CMC information for the IMPD.

The radiolabelled API can be sent to the contract research laboratory (CRO), which carries out the GMP manufacturing step to prepare the investigational medicinal product (IMP). Alternatively Selcia can work with a partner company that is able to prepare oral or sterile IV doses in its MHRA-licensed facility.


GMP concepts work is carried out in our state-of-the-art facilities

  • New radiosynthesis laboratories commissioned in 2008 and 2009 


The API is analysed in

  • GLP accredited analytical facility
    • 400MHz and 500 MHz NMR for residual solvent determination
    • Capillary NMR for impurity profiling

Some features of our GMP concepts work include: 

  • Quarantine and identity testing of raw materials
  • Production area clean down verification
  • Accurate recording of experimental procedures and witnessing of critical processes
  • Rigorous analytical procedures to establish product identity and quality
  • Radiochemical stability data
  • Quarantine and release of API by our internal QA to the QP

Please contact us for more infomation and request our GMP concepts questionnaire.


Audits of our facilities are always welcome
Selcia QA