In vivo products
Medical or clinical use of EURISO-TOP's products
EURISO-TOP has been committed to providing IN VIVO product line for many
years on the market of Isotope Labelled Metabolic Tracers. The
production follows strict guidelines agreement (active substances - EU GMP part
II) and passes thorough Quality Control testings. IN VIVO products are expected
to meet the specifications of European monograph testing.
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.
Using These Research Products for Clinical Trials may require the approval from the health authorities or other comparable government agency in the country of use. EURISO-TOP may provide supporting information such as specific analytical and quality assurance protocols data (chemical purity, isotopic enrichment, pyrogenicity, residual solvents, European pharmacopoeia…etc) to assist medical research groups in obtaining approval for the intended use.
The 13C Urea
produced by EURISO-TOP complies with Good Manufacturing Practices (GMP)
for active substances (EU GMP Part II).
to download the GMP document, please click here.
In addition
EURISO-TOP manufactures highly pure research compounds which are produced for
research applications. All EURISO-TOP’s in vivo products are packaged under a laminar
flow hood, this process of an enclosed bench is designed to prevent
contamination of the material during and permits to provide its customers with
the guarantee of the highest quality products.
Laminar flow hood
