Abstract: A self-referencing radiation detector to test the radiochemical purity of a sample radiopharmaceutical solution. In some embodiments, the self-referencing radiation detector measures the radioactivity of a sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through a high performance liquid chromatography column. The radiation detector then measures the radioactivity of each separated molecularly distinct species from the high performance liquid chromatography column. The radiochemical purity of the sample radiopharmaceutical solution is calculated by comparing the measured radioactivity of separated molecularly distinct species from said high performance liquid chromatography column to the measured radioactivity of the sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through the high performance liquid chromatography column.

Abstract: A self-referencing radiation detector to test the radiochemical purity of a sample radiopharmaceutical solution. In some embodiments, the self-referencing radiation detector measures the radioactivity of a sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through a high performance liquid chromatography column. The radiation detector then measures the radioactivity of each separated molecularly distinct species from the high performance liquid chromatography column. The radiochemical purity of the sample radiopharmaceutical solution is calculated by comparing the measured radioactivity of separated molecularly distinct species from said high performance liquid chromatography column to the measured radioactivity of the sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through the high performance liquid chromatography column.

Abstract: A microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography (PET). The radiopharmaceutical production system includes a reaction vessel that receives a radioisotope from an accelerator or other radioisotope generator. Organic and aqueous reagents are introduced into the reaction vessel, and the mixture is heated to synthesize a solution of a pre-selected radiopharmaceutical. The radiopharmaceutical solution is purified by passing the solution through a solid phase extraction column and a filter. The synthesis process produces per run a quantity of radiopharmaceutical approximately equal to, but not less than, one (1) unit dose of a radiopharmaceutical, reducing waste and allowing for the production of radiopharmaceutical on an as-needed basis.

Abstract: A sample card and automated quality control module for a radiopharmaceutical synthesis system for conducting quality control tests on approximately one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography. The sample card and quality control module allow operators to conduct quality control tests in reduced time using micro-scale test samples from the radiopharmaceutical solution. The sample card works in conjunction with a microfluidic radiopharmaceutical synthesis system to collect samples of radiopharmaceutical solution on the scale of 5-20 microliters per sample. The sample card then interacts with the quality control module to feed the samples into a number of test vessels, where the samples undergo a number of automated quality control tests.

Abstract: A microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography (PET). The radiopharmaceutical production system includes a reaction vessel that receives a radioisotope from an accelerator or other radioisotope generator. Organic and aqueous reagents are introduced into the reaction vessel, and the mixture is heated to synthesize a solution of a pre-selected radiopharmaceutical. The radiopharmaceutical solution is purified by passing the solution through a solid phase extraction column and a filter. The synthesis process produces per run a quantity of radiopharmaceutical approximately equal to, but not less than, one (1) unit dose of a radiopharmaceutical, reducing waste and allowing for the production of radiopharmaceutical on an as-needed basis.