SASAI Online Order Form – EANM EARL

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Note: cost is net in Euros and without VAT included. The Austrian VAT is 20%, and it has to be paid by all non-EU entities, all EU non-entrepreneur entities and all Austrian entities.

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ABX

Please note that ABX reviews all audit report orders and approves only those that have been previously purchased from ABX.

ABX Audit Reports(Required)

ABX General GMP Part purchased alone

ABX General GMP Part and all of the individual product reports noted below purchased all together

ABX General GMP Part and any one of the individual product reports noted below purchased together

Individual ABX product reports:(Required)

ABX Cassette for ⁶⁸Ga-labeleld peptides

ABX O-18 Water

ABX Precursor for [⁶⁸6a]Ga-DOTATOC

ABX Reagent Set for Synthesis [¹⁸F]F-PSMA 1007

ABX Sterile evacuated vials

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Cassette for ⁶⁸Ga-labeleld peptides

ABX product number is GA-01-H. The cassette is designed as single-use material to be used in combination with automated synthesizers such as GE TRACERlab MX and ORA Neptis RS synthesizer for the manufacturing of 68Ga-labelled peptides. Manufacturing and testing procedures were inspected on a randomly chosen lot (GA-H-220310001-1).

O-18 Water

O-18 water is used to produce F-18 by a p,n reaction in a cyclotron. F-18 is the mostly used nuclide in Positron Emission Tomography.

Precursor for [⁶⁸6a]Ga-DOTATOC

ABX product number: 9702 DOTA-TOC acetate (GMP) DOTATOC is a cyclic peptide consisting of eight amino acids to which the chelator DOTA is coupled. It serves as the precursor molecule in the radiosynthesis of [⁶⁸Ga]Ga-DOTATOC, which is obtained usually by the reaction of [⁶⁸Ga]GaCl3 with micromolar amounts of DOTATOC at elevated temperatures. These reactions are often carried out by means of automated cassetteu0002based synthesis modules. For the corresponding reaction cassette refer to product GA-01-H.

Reagent Set for Synthesis [¹⁸F]F-PSMA 1007

ABX's product number is PS-101. The reagent set is used in combination with a disposable singleu0002use cassette for the automated manufacturing of [¹⁸F]F-PSMA-1007 on platforms like GE TRACERlab® MX, GE TRACERlab® FX, Sumitomo MPS200, TRASIS AllinOne, ORA NEPTIS® Plug, Perform, RS and DB synthesizer. The reagent set consists of both chemical components and single-use disposables as listed below: - DMSO - EtOH - PBS buffer - EtOH 30% solution in water for injection - EtOH for water bag - Sodium ascorbate - Water for injection - Purification cartridges o Anion exchange cartridge (PS-H+) o C18ec cartridge - Filters o Cathivex GV o Millex-15 - Syringes and cannulas Product inspection was performed on lot number PS-101-230306001-1. The precursor molecule PSMA-1007 is not part of the reagent set but is sold as a separate product as well as the cartridge for [¹⁸F]fluoride separation (preconditioned SEP PAK QMA light, carbonate as counterion) and the phase transfer catalyst (tetrabutylammonium hydrogen carbonate aqueous solution)

Sterile evacuated vials

ABX product number 8680: 10 ml vials, sterilized by steam sterilization, evacuated The vials can be used by customers for a number of different purposes, such as filling, and storage of customer-prepared solutions used in the manufacturing of radiopharmaceuticals. The SASAI team inspected the manufacturing and quality control of closed sets of vials, rubber stoppers, and caps. The individual materials such as glass type and rubber brand were not inspected for suitability.

CUP Laboratorien Dr. Freitag GmbH

CUP General GMP Part

Inclusive of inclusive of Microbiology and Physical/chemical laboratory specifically audited departments

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ABX

CUP Laboratorien Dr. Freitag GmbH

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