Code NameINC670P-GMP UREA 13C - GMP GradeIND575P-GMP GLYCEROL [1,1,2,3,3-D5) - GMP GradeIND570P-GMP D-GLUCOSE [6,6-D2] - GMP GradeIND590P-GMP L-LEUCINE [5,5,5-D3] - GMP GradeINC586P-GMP L-LEUCINE [1-13C] - GMP Grade

Experiment confident clinical trials with GMP grade substrates !

For more than 20 years Euriso-top has been manufacturing non-radioactive stable isotope labeled compounds (carbon-13, deuterium, nitrogen-15, oxygen-18) and accompanying you in your studies requiring non-invasive diagnostic techniques. 

In 2012, the ANSM (French national agency for the safety of medicinal products and health products), the competent authority in France, renewed our certificate of Good Manufacturing Practice (GMP) compliance as a manufacturer, and extended our certification from one to five active substances (certificate N° HMP/FR/115/2012 of October, 5th, 2012).  

Good Manufacturing Practice for active substances (EU GMP Part II) are applied in Europe to ensure the high level of quality required by health care professionals. They provide reassurance that technical evaluations are carried out systematically, with the aim of satisfying quality standards concerning the specific use of active substances.

�Chemical purity (>99%) : HPLC, 13C-NMR, 1H-NMR, assay of European Pharmacopoeia (Eur. Ph.)

Isotopic enrichment (>99 atom %) : GC/MS, 1H-NMRResidual 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 Fisher, Eur. Ph. (2.2.32)Other assays of the Eur. Ph.

In order to optimize the quality of our active substances, our QC laboratory carries out analyses according to internal monographs and European Pharmacopoeia methods. Chemical and biological analyses are performed at different stages of the manufacturing process:

We inform that persons intending to use these products in applications involving humans do so at their own responsibility and must comply with all appropriate regulations.

GMPCERTIFIED

SUBSTRATES

Moreover, we can offer you other active substances listed with the ANSM. These products are manufactured, packaged and analysed according to the same quality assurance system.

Quality Assurance

To help your pharmacists taking their responsibilities concerning use of an active substance, each product is delivered with a certificate of analysis confirming its compliance with the specifications mentioned in terms of chemical and biological purity and isotopic enrichment.  

Upon your request, we can propose to provide you with a technical document known as the «Manufacturing Summary», which contains the manufacturing certificate, a BSE/TSE certificate, an outline synthesis, the certificate of analysis of the raw materials, the CoA and the analysis of the active substance. Please note that this service is subject to duly notified conditions.

Products of incomparable quality (GMP) An available, reactive customer service (MSDS, CoA, manufacturing summary, quick delivery shipments) Technical and regulatory assistance of your Qualified Pharmacist by our Quality Assurance Manager

A catalogue for a wide range of medical applications A relationship with health care professionals which is based on trust

Code NameD216L-SP DEUTERIUM OXIDE (99.85%D)INO660P 10% 18O ENRICHED NORMALIZED WATERINC507P AMINOPYRINE [N, N-Dimethyl 13C2]INC582P LACTOSYLUREA [UREA-13C]INC610P OCTANOIC ACID [1-13C]INC639P SODIUM ACETATE [1-13C]INC650P MIXED TRIGLYCERIDE - [2-OCTANOYL(1-13C)–

1.3 DISTEAROYL GLYCEROL]INC590P METHACETIN [METHOXY-13C]IND625P L-PHENYLALANINE [RING-D5]INK579P LACTOSYLUREA [UNLABELED]

All substratesare delivered with

a Certificate of Analysis and

a MSDS!

We inform that persons intending to use these products in applications involving humans do so at their own responsibility and must comply with all appropriate regulations.

For more information:www.eurisotop.comTel: + 33 1 69 41 95 96sales@eurisotop.com

PackagingAll in vivo Euriso-top products are packaged in a laminar flow hood by our qualified staff:

To prevent contamination of the material

To guaranty the highest quality products.