title: Preparation of 99mTc-MAG3: radiochemical purity is affected by the residence time of sodium chloride injection in a three-part syringe.
abstract: BACKGROUND
  Routine technetium-99m mercaptoacetyltriglycine (99mTc-MAG3) radiochemical purity measurements have revealed occasional unacceptably low values. Preliminary investigations suggested a causal link with the residence time of sodium chloride injection in the syringe used to reconstitute the MAG3 kit.
  
  
  OBJECTIVE
  To investigate the cause of this phenomenon, determine how it can be avoided and establish whether it occurs with other 99mTc radiopharmaceuticals.
  
  
  METHODS
  99mTc-MAG3 was prepared by drawing sodium chloride injection into a lubricated, three-part, 10 ml Plastipak syringe and using it to reconstitute a MAG3 kit immediately or after a 15 min incubation period. The radiochemical purity was measured by high-performance liquid chromatography. The experiment was repeated using lubricant-free, two-part, Norm-Ject syringes and lubricated, two-part, Monoject syringes (15 min incubation only). To investigate the influence of Plastipak's rubber components on the radiochemical purity, samples were prepared using sodium chloride injection that had been incubated with lubricated or lubricant-free rubber plunger ends. Similar experiments were performed to determine the effect of Plastipak on 99mTc-exametazime, 99mTc-sestamibi and 99mTc-tetrofosmin.
  
  
  RESULTS
  The radiochemical purities of 99mTc-MAG3 prepared with sodium chloride injection incubated for 0 and 15 min in Plastipak syringes were 96.4+/-0.5% and 89.4+/-5.5%, respectively. The difference was significant (P<0.05, n=10). With Norm-Ject syringes, the radiochemical purities were 96.5+/-0.5% and 96.6+/-0.5%, respectively. The difference was not significant (P>0.05, n=10). With Monoject syringes, the radiochemical purity was 96.6+/-0.4% (n=10). 99mTc-MAG3 prepared using sodium chloride injection treated with lubricated and unlubricated syringe rubber plunger ends had radiochemical purities of 85.3+/-6.6% and 82.1+/-6.5% (n=5), respectively. The radiochemical purities of other 99mTc radiopharmaceuticals prepared using sodium chloride injection incubated for 0 or 15 min in Plastipak syringes were as follows: 99mTc-exametazime, 95.3+/-0.6% and 94.5+/-1.8%; 99mTc-sestamibi, 98.0+/-0.6% and 97.7+/-0.6%; 99mTc-tetrofosmin, 96.5+/-0.2% and 97.0+/-0.4%. None of the differences was significant (P>0.05, n=5).
  
  
  CONCLUSIONS
  A lipophilic impurity, originating from the rubber plunger of a three-part Plastipak syringe, is formed in 99mTc-MAG3 when the sodium chloride injection used to reconstitute the kit is in the syringe for a prolonged time. The effect is eliminated by using a two-part syringe or by injecting the sodium chloride injection into the kit immediately. The phenomenon does not occur with 99mTc-exametazime, 99mTc-sestamibi or 99mTc-tetrofosmin.
authors.affiliation: Radiopharmacy, The Royal Infirmary of Edinburgh, Edinburgh, UK. clint.c.waight@luht.scot.nhs.uk
authors.forename: Clinton C
authors.initials: CC
authors.lastname: Waight
authors.forename: Lynn A
authors.initials: LA
authors.lastname: Beattie
authors.forename: Lesley M
authors.initials: LM
authors.lastname: O'Brien
authors.forename: Alistair M
authors.initials: AM
authors.lastname: Millar
mesh_terms: D004340:Drug Contamination / Q000517:prevention & control*; D019544:Equipment Failure Analysis; D007553:Isotope Labeling / Q000295:instrumentation* / Q000379:methods*; D011785:Quality Assurance, Health Care; D019275:Radiopharmaceuticals / Q000032:analysis / Q000138:chemical synthesis; D012965:Sodium Chloride / Q000737:chemistry*; D013048:Specimen Handling / Q000295:instrumentation / Q000379:methods; D013594:Syringes; D017263:Technetium Tc 99m Mertiatide / Q000032:analysis* / Q000138:chemical synthesis*
chemical_list: D019275:Radiopharmaceuticals; D017263:Technetium Tc 99m Mertiatide; D012965:Sodium Chloride