1. Home
  2. Applications
  3. Materials & Industrial Applications
  4. cGMP SUBSTRATES

cGMP SUBSTRATES

Experiment confident clinical trials with cGMP-grade substrates

For more than 30 years Euriso-top has been manufacturing non-radioactive stable isotope-labeled compounds (carbon-13, deuterium, nitrogen-15, oxygen-18).

In 2020, the ANSM (French national agency for the safety of medicinal and health products), the competent authority in France, renewed our certificate of Good Manufacturing Practice (EU GMP) compliance as a manufacturer for a part of our catalog. Euriso-Top has manufactured bulk active pharmaceutical ingredients (APIs) since 1994. It recently added a new facility complex, right in the middle of the CEA Saclay, to complement its existing cGMP facilities.

EU GMP certified
Manufacturing since 1994
mg to multi-kg scale

Quality Control

All our active substances are analyzed according to internal monographs and European Pharmacopoeia methods. Chemical and biological analyses are performed at different stages of the manufacturing process:

Chemical purity

≥ 98%/99% — HPLC, 13C-NMR, 1H-NMR, Eur. Ph. assay

Isotopic enrichment

≥ 98%/99% — GC/MS, LC/MS, 1H-NMR

Residual solvents

GC (Head space), Eur. Ph. (2.2.28)

Endotoxins

LAL test, Eur. Ph. (2.6.14)

Bioburden

Eur. Ph. (2.6.12)

Heavy metals

Eur. Ph. (2.4.8)

Water content

Karl Fischer, Eur. Ph. (2.5.12)

Additional testing

Other Eur. Ph. assays as required

🔬 Why partner with us for cGMP projects

As part of the Cambridge Isotope Laboratories network, we operate among the world's largest 13C and 18O isotope-separation plants, giving us direct control over raw material supply. Production scales flexibly from milligram to multi-kilogram quantities, supporting projects from early clinical trials to commercial-scale API manufacturing, for academic, biotech, and pharmaceutical partners alike.