Preparing 99m Tc-MAG3 using SCI from plastic ampoules that have been exposed to light causes reduced RCP. Exposure of plastic ampoules to light causes leaching of many compounds into the solution. An unknown leached compound destabilizes the 99m Tc-tartrate intermediate complex.
Background:The European Pharmacopoeia and radiopharmaceutical manufacturers specify Instant Thin-Layer Chromatography Silica Gel impregnated glass fibre (ITLC-SG) as the stationary phase for measuring the radiochemical purity (RCP) of most technetium-99m ( 99m Tc) radiopharmaceuticals. During 2008, The Pall Corporation stopped manufacturing ITLC-SG. A replacement is required. Aim: To evaluate Varian's Glass Microfibre Chromatography Paper impregnated with salicic acid (GMCP-SA) as a replacement. Experimental: Samples of six 99m Tc radiopharmaceuticals (albumin nanocolloid, colloidal tin, exametazime, medronate, pentetate and succimer) were prepared containing levels of radiochemical impurities between 0 and 10%. Samples were tested using ITLC-SG and GMCP-SA with the mobile phase specified in the pharmacopoeia or by the manufacturer. Analysis was performed by thin-layer radiochromatogram scanning. Results: For measuring the RCP of albumin nanocolloid, colloidal tin, exametazime and succimer, GMCP-SA is a suitable replacement for ITLC-SG. For medronate, GMCP-SA is suitable for measuring colloidal 99m Tc impurity despite producing slightly higher values than ITLC-SG, but unsuitable for measuring 99m Tc pertechnetate impurity due to significant over-estimation. For pentetate, GMCP-SA is suitable for measuring colloidal 99m Tc impurity but gives slightly higher values for 99m Tc pertechnetate impurity than ITLC-SG. Conclusion: GMCP-SA is a suitable alternative to ITLC-SG for analysing some 99m Tc radiopharmaceuticals but is not a universal replacement.
A capped 3 ml Plastipak syringe is a suitable container in which to supply 99mTc-Nanocoll. Neither passage through an R-Lock nor mixing with Patent Blue V affects the quality of 99mTc-Nanocoll.
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.
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