An evaluation of GMCP-SA as a replacement for ITLC-SG when measuring the levels of radiochemical impurities in 99mTc radiopharmaceuticals by thin-layer chromatography
✍ Scribed by Alistair M. Millar; Lynn A. Beattie; Fiona Craig; Lesley M. O'Brien
- Publisher
- John Wiley and Sons
- Year
- 2009
- Tongue
- French
- Weight
- 127 KB
- Volume
- 52
- Category
- Article
- ISSN
- 0022-2135
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✦ Synopsis
Abstract
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. Copyright © 2009 John Wiley & Sons, Ltd.