KIPROS
FAQs

(1) What‘s the time for a complete production cycle
of [¹²³I]-NaI-FZK?
Duration of irradiation t₁ is governed by the required amount of activity [123-I] [1] with typical numbers being from 3 up to 8 hours. Build-up time t₂ for the accumulation of [123-I] from [123-Xe] [2] is between 4 and 6 hours. Radiochemical preparation including dispensing and packaging take t₃ about 2.5 hours.
In total one batch from beginning of irradiation until shipment requires 10 to 16 hours.

(2) At what time of the day can [¹²³I]-NaI-FZK be delivered?
For a usual manufacturing scheme irradiation takes place during afternoon/evening of a particular day, followed by the radiochemical preparation and shipment the next morning. Depending on duration of transportation the product can earliest be available for the customer at noon the day after irradiation.

Another typical manufacturing scheme for large amounts of ordered activity schedules irradiation during the day with radiochemical preparation in the late evening and over-night shipment. Like this, depending on duration of transportation the product can earliest be available for the customer in the morning of the day after irradiation.

(3) What are the necessary precautions for shipment
of [¹²³I]-NaI-FZK?
[¹²³I]-NaI-FZK is shipped as a dangerous good Type A according to ADR regulations [3, 4, 5].
Given a 1cm Pb-shielding around the product vial, calculations of the dose deposition [6] yield approximately 100 µSv/h per 1 GBq at a distance of 5 cm (= outer surface of the package).

(4) What‘s the shelf life of [¹²³I]-NaI-FZK?
With consideration of the half-life of [123-I] (= 13.2 h) the shelf life of the product is governed by two aspects:

• Usage of the product by the customer: labeling of a precursor and subsequent application to patients or just for experimental purposes;
• initial ratio of [121-Te] [7]: for [¹²³I]-NaI-FZK ZAG specifies a radionuclidic purity of at least 99.7 % until the end of the shelf life. Due to the longer half-life of [121-Te] (= 19.1 d) compared with [123-I] the ratio of [121-Te] steadily increases, i.e. the shelf life as given on the certificate of analysis (CoA [8]) is defined by ZAG as that point in time, at which the specification for radionuclidic purity will be violated. At a typical ratio of [121-Te] of 0.005 % at the end of production, it will take about 82 hours (= 3.4 d) after end of production until the ratio exceeds 0.3 %.

(5) How is the pharmaceutical quality of [¹²³I]-NaI-FZK confirmed?
Radiochemical purity and radiochemical identity are confirmed by thin-layer chromatography.
Radionuclidic purity and radionuclidic identity are confirmed by gamma-spectrometry.

(6) What‘s the regulatory status of [¹²³I]-NaI-FZK?
ZAG Zyklotron AG commercializes [¹²³I]-NaI-FZK as a radiochemical, i.e. as „Active Substance Starting Material“ (refer to Eudralex, 1.2 [9]). From a regulatory point of view, adherence to GMP regulations is not mandatory for such a product. Nevertheless, in the manufacture of the product, ZAG applies quality assurance, which closely resembles quality measures for a radiopharmaceutical.
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Nuclidedata

[1] [123-I]: https://www.nndc.bnl.gov/nudat2/reCenter.jsp?z=53&n=70

[2] [123-Xe]: https://www.nndc.bnl.gov/nudat2/reCenter.jsp?z=54&n=69

[7] [121-Te]: https://www.nndc.bnl.gov/nudat2/reCenter.jsp?z=52&n=69

Type A according to ADR regulations:

[3]: https://www.unece.org/trans/danger/publi/unrec/rev20/20files_e.html

[4]: https://www.bmvi.de/EN/Topics/Mobility/Freight-Transport-Logistics/Dangerous-Goods/dangerous-goods.html

[5]: https://www.fmcsa.dot.gov/regulations/hazardous-materials/hazardous-materialsdangerous-goods-regulations
 

[6] Calculation of dose deposition : http://www.radprocalculator.com/Gamma.aspx

[8] CoA (Certificate of Analysis)

[9] Eudralex, 1.2: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2014-08_gmp_part1.pdf