SUMMARY: OBJECT. The aim of this work was to study the influence of the nature (pH, plastic or glass ampoules) of 0,9% NaCl sodium chloride injection used to dilute generator produced sodium pertechnetate at 1, 2 , 5 mL for Ceretec™ (GE Healthcare, UK) reconstitution on the radiochemical purity (RCP) stability and pH of Technetium-99m-d,l-hexameththylpropyleneamineoxime (99mTc-d,l-HMPAO). MATERIAL AND METHODS. 99mTc-d,l-HMPAO is prepared using commercially available freeze-dried kits according to the procedure specified by the manufacturer. Kits were reconstituted with 1, 2 or 5 mL of fresh (not more 2 h old) generator eluted sodium [99mTc]pertechnetate coming from a generator eluted not more than 24 h in 0,9% NaCl containing 0,074-0,22 GBq/mL. The specified radioactive concentration was obtained by diluting generator eluted sodium [99mTc]pertechnetate with 0,9% NaCl Sodium Chloride Injection coming from stored away from light sources plastic ampoules and Sodium Chloride Injection from glass ampoules. The radiochemical purity of 99mTc-d,l-HMPAO was measured at 0, 15 and 30 min after preparation and was determined by methods specified by the manufacture. RESULTS. We found no influence on the radiochemical purity and stability ( at 30 min following the preparation) of 99mTc-HMPAO based on the type and the pH of sodium chloride injection used for pertechnetate diluting. RCP values decreased proportionally with the decrease of the final volume of preparation and in particular for 1 mL of diluted pertechnetate, the PCR at 30 minutes following the preparation is less than the required (80%). Finally we found that pH average for 99mTc-d,l-HMPAO is lower than indicated by the manufacturer (9,0-9,8). CONCLUSION. This work revelated that instability of the neutral lipophilic 99mTc-d,l-HMPAO complex has a faster onset in reconstituted kits with volumes smaller than 2 mL of pertechnetate, as required for routine preparations for in vitro leukocyte labelling. Iin particular the 1 mL recconstitution kit should not be used beyond the 15 minutes after preparation. This suggests that any protocols that involve volumes smaller than 2 mL of pertechnetate for the Ceretec™ reconstitution should be carefully evaluated in terms of stability of the product.

Radiochemical purity and stability of 99mTc-HMPAO preparations:the influence of pH, volume recovery, and storage conditions

UCCELLI, Licia;BOSCHI, Alessandra
2012

Abstract

SUMMARY: OBJECT. The aim of this work was to study the influence of the nature (pH, plastic or glass ampoules) of 0,9% NaCl sodium chloride injection used to dilute generator produced sodium pertechnetate at 1, 2 , 5 mL for Ceretec™ (GE Healthcare, UK) reconstitution on the radiochemical purity (RCP) stability and pH of Technetium-99m-d,l-hexameththylpropyleneamineoxime (99mTc-d,l-HMPAO). MATERIAL AND METHODS. 99mTc-d,l-HMPAO is prepared using commercially available freeze-dried kits according to the procedure specified by the manufacturer. Kits were reconstituted with 1, 2 or 5 mL of fresh (not more 2 h old) generator eluted sodium [99mTc]pertechnetate coming from a generator eluted not more than 24 h in 0,9% NaCl containing 0,074-0,22 GBq/mL. The specified radioactive concentration was obtained by diluting generator eluted sodium [99mTc]pertechnetate with 0,9% NaCl Sodium Chloride Injection coming from stored away from light sources plastic ampoules and Sodium Chloride Injection from glass ampoules. The radiochemical purity of 99mTc-d,l-HMPAO was measured at 0, 15 and 30 min after preparation and was determined by methods specified by the manufacture. RESULTS. We found no influence on the radiochemical purity and stability ( at 30 min following the preparation) of 99mTc-HMPAO based on the type and the pH of sodium chloride injection used for pertechnetate diluting. RCP values decreased proportionally with the decrease of the final volume of preparation and in particular for 1 mL of diluted pertechnetate, the PCR at 30 minutes following the preparation is less than the required (80%). Finally we found that pH average for 99mTc-d,l-HMPAO is lower than indicated by the manufacturer (9,0-9,8). CONCLUSION. This work revelated that instability of the neutral lipophilic 99mTc-d,l-HMPAO complex has a faster onset in reconstituted kits with volumes smaller than 2 mL of pertechnetate, as required for routine preparations for in vitro leukocyte labelling. Iin particular the 1 mL recconstitution kit should not be used beyond the 15 minutes after preparation. This suggests that any protocols that involve volumes smaller than 2 mL of pertechnetate for the Ceretec™ reconstitution should be carefully evaluated in terms of stability of the product.
2012
A. L., Viglietti; G., Perlo; C., Augeri; C., Massara; S., Zaccaria; Uccelli, Licia; Boschi, Alessandra
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11392/1729899
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