Introduction: The radiopharmaceutials are considered as special group of medicine and its preparation and use are regulated by a number of recommendation or rules adopted in many countries. The development of ⁹⁹Mo/^99mTc generators and lyophilized kits contributed for an ease and fast preparation of 99mTc compounds in hospital radiopharmacies due to the existence and chemical versatility of ^99mTc and its ideal radionuclide characteristics. Radiopharmaceutical products must be of high routine radiochemical purity (RRP) just before clinical application, because the impurities result in poor quality of image or leading to an erroneous interpretation or diagnosis. The operational level of the radiopharmacy and the dispensing area should be a separate, dedicated, secure and close to the imaging and injection areas. The good manufactures practice (GMP) must be applied during the labelling and the quality control assays.

Objective: The aim of this work is to implement and validate the quality control assays of radiopharmaceuticals (lyophilized kits) labeled with ^99mTc, using different chromatographic systems, determining the easy and fast assay for radiochemical quality control in routine, in accordance to the resolution (RDC-38) of Brazilian Health Authorities (ANVISA).

Material and methods: Radionuclide purity tests of ⁹⁹Mo was performed on the first elution from 99Mo/^99mTc generator, the pH, the aluminum ion contamination as well the radiochemical assay, using Whatman3MM chromatography paper in 85% methanol as solvent, were determined before labeling process following manufacturer´s instructions. Radiochemical purity tests of the different kits labeled with ^99mTc were performed, using different chromatographic systems: 1) solvent extraction or partition method, 2) solid extraction phase (Sep-Pak C18 filter), 3) TLC-SG (Al) and 4) paper Whatmann 3MM (8 x 1.5cm), in different mobile phases. Personnel involved in production, quality control tests and release of final products were trained in radiopharmaceutical specific aspects.

Results: During April to June of 2012, more than 190 ⁹⁹Mo^99mTc-IPEN generators and 500 kits (MDP; MIBI; DTPA; DMSA; MAA; Phytate; ECD; Hynic-Toc) labeled with ^99mTc were analyzed. All samples presented an acceptable pH values and chemical, radionuclide and radiochemical purity higher than 90 %, according pharmacopeia or to manufacturer’s instruction, which must be necessary to performed before dose administration, following the resolution RDC-38.

Conclusion: The paper chromatography and solid extraction phase system were acceptable for RRP tests. The results provided a practice-oriented guidance to the group involved in the preparation and the quality control of radiopharmaceuticals under GMP condition. A comprehensive RRP quality control program were developed and validated at Hospital Radiopharmacy of Albert Einstein Hospital, as well as the adverse events related to the radiopharmaceuticals have been reported.