NANOCIS®: Possible errors in the summary of product characteristics quality control method and a suggested alternative method.

Background: Determination of the radiochemical purity of [Tc]NANOCIS® was performed using the procedure described in the Summary of Product Characteristics (SPC). In contrast to the clinical findings of thyroid gland accumulation indicating free [Tc] pertechnetate, the QC results showed no free [Tc]pertechnetate. This discrepancy prompted us to further investigate the described QC procedure.