Deficiencies in product labelling instructions and quality control directions for 99mTc radiopharmaceuticals

Abstract

The indications in TLs and SPCs should provide useful information for maintaining the quality and purity of the radiopharmaceutical preparation and ensure the safety level and effectiveness required by law. However, the instructions are often suboptimal or even erroneous, and consequently there are countless failures or difficulties, which represent an impediment to good laboratory practice. We believe that a 'smart' review of radiopharmaceutical documentation would be beneficial in order to align these indications to the real needs of the operators involved in routine in-house nuclear medicine practice.

Speciation analysis of Tc radiopharmaceuticals by HPLC-ICP-MS and HPLC-ESI-HRMS

“…This is underpinned by the fact that the short half-life of 99m Tc leaves little time for ne-adjustments of several synthesis parameters (e.g., the exact amount of 99m Tc/ 99 Tc eluting from the generator, pH, O 2 partial pressure, etc.). 9,13 Tc radiopharmaceuticals may contain species in various oxidation states, which can result in a loss of contrast in scintigraphy while exposing patients to unnecessary radiation. 14 The amount and identity of impurities are oen unknown and even slight effects and deviations during synthesis, storage and administration may lead to a signicant quality loss in scintigraphy.…”

“…14 The amount and identity of impurities are oen unknown and even slight effects and deviations during synthesis, storage and administration may lead to a signicant quality loss in scintigraphy. 13,15 It is therefore highly aspired to control and optimize reaction parameters with the aim to improve radiochemical purity, maximize tracer yield and enhance contrast in diagnostic applications.…”

“…). 9,13 Tc radiopharmaceuticals may contain species in various oxidation states, which can result in a loss of contrast in scintigraphy while exposing patients to unnecessary radiation. 14 The amount and identity of impurities are often unknown and even slight effects and deviations during synthesis, storage and administration may lead to a significant quality loss in scintigraphy.…”