Study Of Extractable And Releasable Substances For A Radioisotope Generator

  Address - Belgium

  Contact details - 565656565

  Tender notice no. - 76454545

  GT Ref Id - 80419986

  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 Elits ger manium-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 generators SCC must be evaluated for extractables and leachables. Reference studies on

Gt Ref Id - 80419986

Deadline - Apr 18, 2024