Study Of Extractable And Releasable Substances For A Radioisotope Generator

  Address - Belgium

  Contact details - 565656565

  Tender notice no. - 76454545

  GT Ref Id - 81599869

  Document Type - Tender Notices

Description - Description: IRE ELiT is one of only two global suppliers of germanium-68 (68Ge) / gallium-68 (68Ga) generators approved as a drug in Europe and as an active ingredient in the United States. Further information on the characteristics of IRE Elit's ge rmanium-68 (68Ge) / gallium-68 (68Ga) radiopharmaceutical generators is available on the website: https://www.ire.eu/medias/318/BE-FR .pdf. Substances that migrate from a container closure system (CCS) into the formulation of a pharmaceutical product can potentially affect its safety, stability and effectiveness. Therefore, as part of regulatory compliance, the generator's SCC must be evaluated for extractables and leachables. Reference studies o

Gt Ref Id - 81599869

Deadline - May 23, 2024