Abstract: The present invention is related to a direct solid sample analytical technology for determining a content and a uniformity thereof in a lyophilized kit of a sulfur-containing chelator with a stable complex capacity for radiotechnetium (Tc-99m) and radiorhenium (Re-186, Re-188). An economical, stable and easily accessible coal standard is used herein as a contrast substance to construct a sulfur calibration curve, followed by obtaining the sulfur content and the uniformity thereof in the solid lyophilized sample by interpolating the foregoing result into the sulfur calibration curve. Then, the weight content percent is converted to get the content and the uniformity of the chelator in the lyophilized kit. The quality control of active pharmaceutical ingredients (API) in the lyophilized kit during key production processes and clinical applications is thus assured.

Abstract: The present invention is related to a direct solid sample analytical technology for determining a content and a uniformity thereof in a lyophilized kit of a sulfur-containing chelator with a stable complex capacity for radiotechnetium (Tc-99m) and radiorhenium (Re-186, Re-188). An economical, stable and easily accessible coal standard is used herein as a contrast substance to construct a sulfur calibration curve, followed by obtaining the sulfur content and the uniformity thereof in the solid lyophilized sample by interpolating the foregoing result into the sulfur calibration curve. Then, the weight content percent is converted to get the content and the uniformity of the chelator in the lyophilized kit. The quality control of active pharmaceutical ingredients (API) in the lyophilized kit during key production processes and clinical applications is thus assured.

Abstract: An analytical technique for determining the structures of serotonin transporter (SERT) imaging agent [123I] ADAM and its precursor, SnADAM by using a high-performance liquid chromatography tandem mass spectrometer (LC-MS/MS) is provided. An analytical technique for determining the purity of SnADAM by using a high-performance liquid chromatograph (HPLC) is also provided.

Abstract: An analytical technique for determining the structures of serotonin transporter (SERT) imaging agent [123I] ADAM and its precursor, SnADAM by using a high-performance liquid chromatography tandem mass spectrometer (LC-MS/MS) is provided. An analytical technique for determining the purity of SnADAM by using a high-performance liquid chromatograph (HPLC) is also provided.

Abstract: A present invention relate to a diethylenetriaminepentaacetic acid (DTPA)-modified ferrofluid and a preparation method of the same. The DTPA-ferrofluid contains DTPA and a nano ferrofluid. The DTPA-ferrofluid can be further mixed with a peptide. Unmodified or modified peptide ferrofluids prepared from the DTPA-modified ferrofluid, such as unmodified or modified octreotide-containing or unmodified or modified lanreotide-containing ferrofluid.

Abstract: The present invention provides a method for measuring and calibrating sample injection volume or mobile phase delivery rate of any type of micropumps or their integrated systems by using the direct proportion of the total activity (or mass) to the delivery rate (or volume) of a radiochemical nuclide with known activity in a certain time period. Also, the present invention may adjust the range of measurement and calibration from micro-liter (?L) to pico-liter (pL) or from ?L/min to pL/min by selecting nuclide species and their concentrations from different liquid calibration radiation sources.

Abstract: A purity of BZM is analyzed by a high performance liquid Chromatography (HPLC) to know whether the purity is qualified. And a quantity of a labeled ligand ([123I] IBZM) and a quantity of a free ligand (BZM) are analyzed by a liquid chromatograph tandem mass spectrometer (LC-MS/MS). The analysis result is used for maintaining a stable and qualified imaging agent. By maintaining the imaging agent, image interferences from background and receptor number are prevented.

Abstract: This invention discloses a novel technology for the purity assay of TRODAT-1 raw material by reverse phase high performance liquid chromatography (RP-HPLC). The method for TRODAT-1 raw material purity assay of this present invention includes using high performance liquid chromatography (HPLC), liquid chromatography tandem mass spectrometry (LC-MS/MS), HPLC column, preparation of samples, regents and eluent as well as performing parent and product ion analysis by mass spectrometry for the method validation, calculation of chromatographic resolutions and raw material purity. This invention discloses the first in the world of purity assay for TRODAT-1 raw material through elaborated validation procedures.

Abstract: This invention discloses a novel technology for the impurities assay of TRODAT-1 raw material by reverse phase high performance liquid chromatography (RP-HPLC). The method for TRODAT-1 raw material impurities assay of this present invention includes using high performance liquid chromatography (HPLC), liquid chromatography tandem mass spectrometry (LC-MS/MS), HPLC column, preparation of samples, regents and eluent as well as performing parent and product ion analysis by mass spectrometry for the method validation, calculation of chromatographic resolution and raw material impurities. This invention is the first report in the world that proved the existence of oligomers in TRODAT-1 raw material, as well as an analytical method through elaborated validation procedures to quantify the impurities (including the oligomers) in TRODAT-1 raw material.

Abstract: The present invention provides a method for measuring and calibrating sample injection volume or mobile phase delivery rate of any type of micropumps or their integrated systems by using the direct proportion of the total activity (or mass) to the delivery rate (or volume) of a radiochemical nuclide with known activity in a certain time period. Also, the present invention may adjust the range of measurement and calibration from micro-liter (?L) to pico-liter (pL) or from ?L/min to pL/min by selecting nuclide species and their concentrations from different liquid calibration radiation sources.